Atomoxetine Hydrochloride (Page 9 of 9)

14.2 ADHD Studies in Adults

The effectiveness of atomoxetine in the treatment of ADHD was established in 2 randomized, double-blind, placebo-controlled clinical studies of adult patients, age 18 and older, who met DSM-IV criteria for ADHD.

Signs and symptoms of ADHD were evaluated using the investigator-administered Conners Adult ADHD Rating Scale Screening Version (CAARS), a 30-item scale. The primary effectiveness measure was the 18-item Total ADHD Symptom score (the sum of the inattentive and hyperactivity/impulsivity subscales from the CAARS) evaluated by a comparison of mean change from baseline to endpoint using an intent-to-treat analysis.

In 2 identical, 10-week, randomized, double-blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either atomoxetine or placebo. Atomoxetine was administered as a divided dose in the early morning and late afternoon/early evening and titrated according to clinical response in a range of 60 to 120 mg/day. The mean final dose of atomoxetine for both studies was approximately 95 mg/day. In both studies, ADHD symptoms were statistically significantly improved on atomoxetine, as measured on the ADHD Symptom score from the CAARS scale.

Examination of population subsets based on gender and age (<42 and ≥42) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Atomoxetine capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap, imprinted “APO AM10” in black ink. They are supplied as follows:

NDC Number Size
51407-100-30 Bottles of 30

Atomoxetine capsules, USP 18 mg are available for oral administration as hard gelatin capsules with a white opaque body and a gold opaque cap, imprinted “APO AM18” in black ink. They are supplied as follows:

NDC Number Size
51407-101-30 Bottles of 30

Atomoxetine capsules, USP 25 mg are available for oral administration as hard gelatin capsules with a white opaque body and a blue opaque cap, imprinted “APO AM25” in black ink. They are supplied as follows:

NDC Number Size
51407-102-30 Bottles of 30

Atomoxetine capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a blue opaque body and a blue opaque cap, imprinted “APO AM40” in black ink. They are supplied as follows:

NDC Number Size
51407-103-30 Bottles of 30

Atomoxetine capsules, USP 60 mg are available for oral administration as hard gelatin capsules with a gold opaque body and a blue opaque cap, imprinted “APO AM60” in black ink. They are supplied as follows:

NDC Number Size
51407-104-30 Bottles of 30

Atomoxetine capsules, USP 80 mg are available for oral administration as hard gelatin capsules with a white opaque body and an orange opaque cap, imprinted “APO AM80” in black ink. They are supplied as follows:

NDC Number Size
51407-105-30 Bottles of 30

Atomoxetine capsules, USP 100 mg are available for oral administration as hard gelatin capsules with an orange opaque body and an orange opaque cap, imprinted “APO AM100” in black ink. They are supplied as follows:

NDC Number Size
51407-106-30 Bottles of 30

16.2 Storage and Handling

Store atomoxetine capsules, USP at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during atomoxetine treatment and when the dose is adjusted. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions ( 5.1)] .

Severe Liver Injury

Patients initiating atomoxetine should be cautioned that severe liver injury may develop. Patients should be instructed to contact their healthcare provider immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms [see Warnings and Precautions ( 5.2)] .

Screening Patients for Bipolar Disorder

Instruct patients and their caregivers to look for signs of activation of mania/hypomania [see Warnings and Precautions ( 5.6)] .

Aggression or Hostility

Instruct patients and their caregivers to contact their healthcare provider as soon as possible should they notice an increase in aggression or hostility [see Warnings and Precautions ( 5.7)] .

Priapism

Rare postmarketing cases of priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with atomoxetine. The parents or guardians of pediatric patients taking atomoxetine and adult patients taking atomoxetine should be instructed that priapism requires prompt medical attention [see Warnings and Precautions ( 5.10)] .

Ocular Irritant

Atomoxetine is an ocular irritant. Atomoxetine capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.

Drug-Drug Interaction

Patients should be instructed to consult a healthcare provider if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies.

Pregnancy Registry

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy [see Use in Specific Populations (8.1)].

Food

Patients may take atomoxetine capsules with or without food.

Missed Dose

If patients miss a dose, they should be instructed to take it as soon as possible, but should not take more than the prescribed total daily amount of atomoxetine in any 24-hour period.

Interference with Psychomotor Performance

Patients should be instructed to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.

APOTEX INC.
ATOMOXETINE CAPSULES, USP 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg

Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 USA 33326

Revision: 12
Revised: February 2022

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

MEDICATION GUIDE

Atomoxetine Capsules, USP

(a” toe mox’ e teen)

Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child’s treatment with atomoxetine.

What is the most important information I should know about atomoxetine capsules?

The following have been reported with use of atomoxetine:

1. Suicidal thoughts and actions in children and teenagers:

Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager’s doctor if your child or teenager (or there is a family history of):

  • has bipolar illness (manic-depressive illness)
  • had suicide thoughts or actions before starting atomoxetine capsules

The chance for suicidal thoughts and actions may be higher:

  • early during atomoxetine treatment
  • during dose adjustments

Prevent suicidal thoughts and action in your child or teenager by:

  • paying close attention to your child or teenager’s moods, behaviors, thoughts, and feelings during atomoxetine treatment
  • keeping all follow-up visits with your child or teenager’s doctor as scheduled

Watch for the following signs in your child or teenager during atomoxetine treatment:

  • anxiety
  • agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility
  • aggressiveness
  • impulsivity
  • restlessness
  • mania
  • depression
  • suicide thoughts

Call your child or teenager’s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

2. Severe liver damage:

Atomoxetine can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:

  • itching
  • right upper belly pain
  • dark urine
  • yellow skin or eyes
  • unexplained flu-like symptoms

3. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting atomoxetine.

Your doctor should check your blood pressure or your child’s blood pressure and heart rate regularly during treatment with atomoxetine.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine.

4. New mental (psychiatric) problems in children and teenagers:

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

Call your child or teenager’s doctor right away about any new mental symptoms because adjusting or stopping atomoxetine treatment may need to be considered.

What are atomoxetine capsules?

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Atomoxetine should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Atomoxetine has not been studied in children less than 6 years old.

Who should not take atomoxetine capsules?

Atomoxetine should not be taken if you or your child:

  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil ® (phenelzine sulfate), Parnate ® (tranylcypromine sulfate) and Emsam ® (selegiline transdermal system).
  • have an eye problem called narrow angle glaucoma
  • are allergic to anything in atomoxetine capsules. See the end of this Medication Guide for a complete list of ingredients.
  • have or have had a rare tumor called pheochromocytoma.

Atomoxetine capsules may not be right for you or your child. Before starting atomoxetine tell your doctor or your child’s doctor about all health conditions (or a family history of) including:

  • have or had suicide thoughts or actions
  • heart problems, heart defects, irregular heart beat, high blood pressure, or low blood pressure
  • mental problems, psychosis, mania, bipolar illness, or depression
  • liver problems
  • are pregnant or plan to become pregnant. It is not known if atomoxetine will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
    • There is a pregnancy registry for females who are exposed to ADHD medications, including atomoxetine, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to atomoxetine and their baby. If you or your child becomes pregnant during treatment with atomoxetine, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/.
  • are breastfeeding or plan to breastfeed. It is not known if atomoxetine passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take atomoxetine.

Can atomoxetine capsules be taken with other medicines?

Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Atomoxetine and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • asthma medicines
  • anti-depression medicines including MAOIs
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking atomoxetine capsules without talking to your doctor first.

How should atomoxetine capsules be taken?

  • Take atomoxetine capsules exactly as prescribed. Atomoxetine capsules come in different dose strength capsules. Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or open the capsules. Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow atomoxetine capsules whole. A different medicine may need to be prescribed.
  • Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine capsule. If any of the powder gets in your eyes or your child’s eyes, rinse them with water right away and call your doctor.
  • Atomoxetine capsules can be taken with or without food.
  • Atomoxetine capsules are usually taken once or twice a day. Take atomoxetine capsules at the same time each day to help you remember. If you miss a dose of atomoxetine, take it as soon as you remember that day. If you miss a day of atomoxetine, do not double your dose the next day. Just skip the day you missed.
  • From time to time, your doctor may stop atomoxetine treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine. Children should have their height and weight checked often while taking atomoxetine. Atomoxetine treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much atomoxetine or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of atomoxetine capsules?

See “What is the most important information I should know about atomoxetine capsules?” for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.

Other serious side effects include:

  • serious allergic reactions (call your doctor if you have trouble breathing, see swelling or hives, or experience other allergic reactions)
  • slowing of growth (height and weight) in children
  • problems passing urine including
    • trouble starting or keeping a urine stream
    • cannot fully empty the bladder

Common side effects in children and teenagers include:

  • upset stomach
  • decreased appetite
  • nausea or vomiting
  • dizziness
  • tiredness
  • mood swings

Common side effects in adults include:

  • constipation
  • dry mouth
  • nausea
  • decreased appetite
  • dizziness
  • sexual side effects
  • problems passing urine

Other information for children, teenagers, and adults:

  • Erections that won’t go away (priapism) have occurred rarely during treatment with atomoxetine. If you have an erection that lasts more than 4 hours, seek medical help right away. Because of the potential for lasting damage, including the potential inability to have erections, priapism should be evaluated by a doctor immediately.
  • Atomoxetine may affect your ability or your child’s ability to drive or operate heavy machinery. Be careful until you know how atomoxetine affects you or your child.
  • Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store atomoxetine capsules?

  • Storeatomoxetine capsulesin a safe place at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F).
  • Keep atomoxetine capsules and all medicines out of the reach of children.

General information about atomoxetine capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine for a condition for which it was not prescribed. Do not give atomoxetine to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about atomoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine capsules that was written for healthcare professionals. For more information call Apotex Corp. at 1-800-706-5575 or visit www.apotex.com.

What are the ingredients in atomoxetine capsules?

Active ingredient: atomoxetine hydrochloride, USP.
Inactive ingredients: The capsules also contain pregelatinized starch. The capsule shells contain gelatin and titanium dioxide. The capsule shells may also contain one or more of the following: FD&C Blue No. 2 (25 mg, 40 mg, and 60 mg), iron oxide red (80 mg and 100 mg), and iron oxide yellow (18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg). The capsules are imprinted with edible black ink (comprised of ammonia solution, iron oxide black, potassium hydroxide, propylene glycol, and shellac.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

All registered trademarks in this document are the property of their respective owners.

APOTEX INC.
ATOMOXETINE CAPSULES, USP 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg

Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 USA 33326

Revision: 12

Revised: February 2022

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 10 MG LABEL

NDC 51407-100-30

Atomoxetine Capsules, USP

Each capsule contains atomoxetine hydrochloride, USP equivalent to 10 mg atomoxetine.

10 mg

Rx only

30 Capsules

//medlibrary.org/lib/images-rx/atomoxetine-hydrochloride-2/51407-100-30ol-atomoxetine-caps-30ct-rev-1123-300x113.jpg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 18 MG LABEL

NDC 51407-101-30

Atomoxetine Capsules, USP

Each capsule contains atomoxetine hydrochloride, USP equivalent to 18 mg atomoxetine.

18 mg

Rx only

30 Capsules

//medlibrary.org/lib/images-rx/atomoxetine-hydrochloride-2/51407-101-30ol-atomoxetine-caps-30ct-rev-1123-300x113.jpg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 25 MG LABEL

NDC 51407-102-30

Atomoxetine Capsules, USP

Each capsule contains atomoxetine hydrochloride, USP equivalent to 25 mg atomoxetine.

25 mg

Rx only

30 Capsules

//medlibrary.org/lib/images-rx/atomoxetine-hydrochloride-2/51407-102-30ol-atomoxetine-caps-30ct-rev-1123-300x112.jpg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 40 MG LABEL

NDC 51407-103-30

Atomoxetine Capsules, USP

Each capsule contains atomoxetine hydrochloride, USP equivalent to 40 mg atomoxetine.

40 mg

Rx only

30 Capsules

//medlibrary.org/lib/images-rx/atomoxetine-hydrochloride-2/atomoxetine-caps-51407-103-30ol-30ct-rev0723-300x113.jpg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 60 MG LABEL

NDC 51407-104-30

Atomoxetine Capsules, USP

Each capsule contains atomoxetine hydrochloride, USP equivalent to 60 mg atomoxetine.

60 mg

Rx only

30 Capsules

//medlibrary.org/lib/images-rx/atomoxetine-hydrochloride-2/51407-104-30ol-atomoxetine-caps-30ct-rev-1123-300x112.jpg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 80 MG LABEL

NDC 51407-105-30

Atomoxetine Capsules, USP

Each capsule contains atomoxetine hydrochloride, USP equivalent to 80 mg atomoxetine.

80 mg

Rx only

30 Capsules

//medlibrary.org/lib/images-rx/atomoxetine-hydrochloride-2/51407-105-30ol-atomoxetine-caps-30ct-rev-1123-300x113.jpg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 100 MG LABEL

NDC 51407-106-30

Atomoxetine Capsules, USP

Each capsule contains atomoxetine hydrochloride, USP equivalent to 100 mg atomoxetine.

100 mg

Rx only

30 Capsules

//medlibrary.org/lib/images-rx/atomoxetine-hydrochloride-2/51407-106-30ol-atomoxetine-caps-30ct-rev-1123-300x113.jpg
(click image for full-size original)
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-100(NDC:60505-2830)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color white (opaque white) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APO;AM10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-100-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078983 05/30/2017
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-101(NDC:60505-2831)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 18 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color white (opaque white) , yellow (opaque gold) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APO;AM18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-101-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078983 05/30/2017
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-102(NDC:60505-2832)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 2
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color white (opaque white) , blue (opaque blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code APO;AM25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-102-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078983 05/30/2017
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-103(NDC:60505-2833)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 2
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color blue (opaque blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code APO;AM40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-103-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078983 05/30/2017
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-104(NDC:60505-2834)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 60 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color yellow (opaque gold) , blue (opaque blue) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code APO;AM60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-104-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078983 05/30/2017
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-105(NDC:60505-2835)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color white (opaque white) , orange (opaque orange) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code APO;AM80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-105-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078983 05/30/2017
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-106(NDC:60505-2836)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color orange (opaque orange) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code APO;AM100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-106-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078983 05/30/2017
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-100), repack (51407-100), relabel (51407-101), repack (51407-101), relabel (51407-102), repack (51407-102), relabel (51407-103), repack (51407-103), relabel (51407-104), repack (51407-104), relabel (51407-105), repack (51407-105), relabel (51407-106), repack (51407-106)

Revised: 12/2023 Golden State Medical Supply, Inc.

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