Kaletra (Page 11 of 11)

14.4 Pediatric Studies

Study 1030 was an open-label, multicenter, dose-finding trial evaluating the pharmacokinetic profile, tolerability, safety and efficacy of KALETRA oral solution containing lopinavir 80 mg/mL and ritonavir 20 mg/mL at a dose of 300/75 mg/m 2 twice daily plus 2 NRTIs in HIV-1 infected infants ≥14 days and <6 months of age.

Ten infants, ≥14 days and <6 wks of age, were enrolled at a median (range) age of 5.7 (3.6-6.0) weeks and all completed 24 weeks. At entry, median (range) HIV-1 RNA was 6.0 (4.7-7.2) log 10 copies/mL. Seven of 10 infants had HIV-1 RNA <400 copies/mL at Week 24. At entry, median (range) CD4+ percentage was 41 (16-59) with a median decrease of 1% (95% CI: -10, 18) from baseline to week 24 in 6 infants with available data.

Twenty-one infants, between 6 weeks and 6 months of age, were enrolled at a median (range) age of 14.7 (6.9-25.7) weeks and 19 of 21 infants completed 24 weeks. At entry, median (range) HIV RNA level was 5.8 (3.7-6.9) log 10 copies/mL. Ten of 21 infants had HIV RNA <400 copies/mL at Week 24. At entry, the median (range) CD4+ percentage was 32 (11-54) with a median increase of 4% (95% CI: -1, 9) from baseline to week 24 in 19 infants with available data [see Clinical Pharmacology ( 12.3) for pharmacokinetic results] .

Study 940 was an open-label, multicenter trial evaluating the pharmacokinetic profile, tolerability, safety and efficacy of KALETRA oral solution containing lopinavir 80 mg/mL and ritonavir 20 mg/mL in 100 antiretroviral naïve (44%) and experienced (56%) pediatric patients. All patients were non-nucleoside reverse transcriptase inhibitor naïve. Patients were randomized to either 230 mg lopinavir/57.5 mg ritonavir per m 2 or 300 mg lopinavir/75 mg ritonavir per m 2. Naïve patients also received lamivudine and stavudine. Experienced patients received nevirapine plus up to two nucleoside reverse transcriptase inhibitors.

Safety, efficacy and pharmacokinetic profiles of the two dose regimens were assessed after three weeks of therapy in each patient. After analysis of these data, all patients were continued on the 300 mg lopinavir/75 mg ritonavir per m 2 dose. Patients had a mean age of 5 years (range 6 months to 12 years) with 14% less than 2 years. Mean baseline CD4+ cell count was 838 cells/mm 3 and mean baseline plasma HIV-1 RNA was 4.7 log 10 copies/mL.

Through 48 weeks of therapy, the proportion of patients who achieved and sustained an HIV-1 RNA < 400 copies/mL was 80% for antiretroviral naïve patients and 71% for antiretroviral experienced patients. The mean increase from baseline in CD4+ cell count was 404 cells/mm 3 for antiretroviral naïve and 284 cells/mm 3 for antiretroviral experienced patients treated through 48 weeks. At 48 weeks, two patients (2%) had prematurely discontinued the study. One antiretroviral naïve patient prematurely discontinued secondary to an adverse reaction, while one antiretroviral experienced patient prematurely discontinued secondary to an HIV-1 related event.

Dose selection in pediatric patients was based on the following:

  • Among patients 14 days to 6 months of age receiving 300/75 mg/m 2 twice daily without nevirapine, plasma concentrations were lower than those observed in adults or in older children. This dose resulted in HIV-1 RNA < 400 copies/mL in 55% of patients (70% in those initiating treatment at <6 weeks of age).
  • Among patients 6 months to 12 years of age, the 230/57.5 mg/m 2 oral solution twice daily regimen without nevirapine and the 300/75 mg/m 2 oral solution twice daily regimen with nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice daily regimen (without nevirapine). These doses resulted in treatment benefit (proportion of patients with HIV-1 RNA < 400 copies/mL) similar to that seen in the adult clinical trials.
  • Among patients 12 to 18 years of age receiving 400/100 mg/m 2 or 480/120 mg/m 2 (with efavirenz) twice daily, plasma concentrations were 60-100% higher than among 6 to 12 year old patients receiving 230/57.5 mg/m 2. Mean apparent clearance was similar to that observed in adult patients receiving standard dose and in patients 6 to 12 years of age. Although changes in HIV-1 RNA in patients with prior treatment failure were less than anticipated, the pharmacokinetic data supports use of similar dosing as in patients 6 to 12 years of age, not to exceed the recommended adult dose.
  • For all age groups, the body surface area dosing was converted to body weight dosing using the patient’s prescribed lopinavir dose.

16 HOW SUPPLIED/STORAGE AND HANDLING

KALETRA ® (lopinavir and ritonavir) tablets and oral solution are available in the following strengths and package sizes:

200 mg lopinavir/50 mg ritonavir

Yellow film-coated ovaloid tablets debossed
with the a logo and the code KA

Store KALETRA tablets at 20°- 25°C (68°- 77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP controlled room temperature]. Dispense in original container or USP equivalent tight container. For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container for longer than 2 weeks is not recommended.

Recommended Storage:

17 PATIENT COUNSELING INFORMATION

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

General Administration Information [see Dosage and Administration ( 2)] :

  • Advise patients to pay special attention to accurate administration of their dose to minimize the risk of accidental overdose or underdose of KALETRA.
  • Advise patients and caregivers that the oral solution should be administered using the calibrated dosing cup (supplied) or oral dosing syringe.
  • Advise caregivers to inform their healthcare provider if the child’s weight changes in order to make sure that the child’s KALETRA dose is adjusted as needed.
  • Inform patients and caregivers that KALETRA tablets may be taken with or without food but KALETRA oral solution should be taken with food to enhance absorption.
  • Advise patients to remain under the care of a healthcare provider while using KALETRA and to take KALETRA in combination with other antiretroviral drugs as prescribed.
  • Advise patients not to alter the dose or discontinue therapy without consulting with their healthcare provider. If a dose of KALETRA is missed patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped the patient should not double the next dose.
  • Inform patients that it is important to take KALETRA on a regular dosing schedule as directed and to avoid missing doses as that can result in development of resistance.
  • Inform patients that there may be a greater chance of developing diarrhea with the once daily regimen as compared with the twice daily regimen.
  • Inform patients that Kaletra is not a cure for HIV-1 infection and that they may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.

Drug Interactions

Inform patients that KALETRA may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription, non-prescription medication or herbal products such as St. John’s Wort [see Contraindications ( 4), Warnings and Precautions ( 5.1) and Drug Interactions ( 7)] .

Pancreatitis

Advise patients that pancreatitis has been observed in patients receiving KALETRA and to alert their healthcare provider if they experience symptoms such as nausea, vomiting or abdominal pain [see Warnings and Precautions ( 5.3)] .

Skin Rash

Inform patients that skin rash ranging in severity from mild to toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, erythema multiforme, urticaria, and angioedema have been reported in patients receiving KALETRA or its components lopinavir and/or ritonavir. Advise patients to contact their healthcare provider if they develop a rash while taking KALETRA [see Adverse Reactions ( 6.1)] .

Hepatotoxicity

Pre-existing liver disease including Hepatitis B or C can worsen with use of KALETRA. This can be seen as worsening of transaminase elevations or hepatic decompensation. Advise patients that their liver function tests will need to be monitored closely especially during the first several months of KALETRA treatment and that they should notify their healthcare provider if they develop the signs and symptoms of worsening liver disease including loss of appetite, abdominal pain, jaundice, and itchy skin [see Warnings and Precautions ( 5.4)] .

QT and PR Interval Prolongation

Advise patients that KALETRA may produce changes in the electrocardiogram (e.g., PR and/or QT prolongation) and to consult their healthcare provider if they experience symptoms such as dizziness, lightheadedness, abnormal heart rhythm or loss of consciousness [see Warnings and Precautions ( 5.5, 5.6)] .

Diabetes Mellitus/Hyperglycemia

Advise patients that new onset of diabetes or exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported during KALETRA use. Advise patients to notify their healthcare provider if they develop the signs and symptoms of diabetes mellitus including frequent urination, excessive thirst, extreme hunger or unusual weight loss and/or an increased blood sugar while on KALETRA as they may require a change in their diabetes treatment or new treatment [see Warnings and Precautions ( 5.7)] .

Immune Reconstitution Syndrome

Advise patients that immune reconstitution syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including KALETRA [see Warnings and Precautions ( 5.8)] .

Lipid Disorders

Advise patients that treatment with KALETRA therapy can result in substantial increases in the concentration of total cholesterol and triglycerides [see Warnings and Precautions ( 5.9)] .

Fat Redistribution

Advise patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long term health effects of these conditions are not known at this time [see Warnings and Precautions ( 5.10)] .

Patients with Hemophilia

Advise patients with hemophilia that they may experience increased bleeding when treated with protease inhibitors such as KALETRA [see Warnings and Precautions ( 5.11)] .

Pregnancy Exposure Registry

Inform patients that there is an antiretroviral pregnancy registry that monitors fetal outcomes of pregnant women exposed to KALETRA [see Use in Specific Populations ( 8.1)] .

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations ( 8.2)] .

Manufactured by AbbVie Inc., North Chicago, IL 60064 USA

KALETRA is a trademark of AbbVie Inc.

The brands listed are trademarks of their respective owners and are not trademarks of AbbVie Inc. The makers of these brands are not affiliated with and do not endorse AbbVie Inc. or its products.

© 2020 AbbVie Inc. All rights reserved.

20065455

MEDICATION GUIDE
KALETRA ® (kuh-LEE-tra) (lopinavir and ritonavir) tablets KALETRA ® (kuh-LEE-tra) (lopinavir and ritonavir) oral solution

What is the most important information I should know about KALETRA?

KALETRA may cause serious side effects, including:

  • Interactions with other medicines. It is important to know the medicines that should not be taken with KALETRA. For more information, see “Who should not take KALETRA?”
  • Side Effects in babies taking KALETRA oral solution. KALETRA oral solution contains alcohol (ethanol) and propylene glycol. Call your healthcare provider right away if your baby appears too sleepy or their breathing changes.
  • Inflammation of your pancreas (pancreatitis). KALETRA can cause pancreatitis which may be serious and may lead to death. People who have high levels of a certain fat (triglycerides) have a risk for developing pancreatitis. If you have advanced HIV-1 disease, you may have an increased risk of high triglyceride levels in your blood, and pancreatitis. If you have a history of pancreatitis, you may have an increased risk of it coming back again during treatment with KALETRA. Tell your healthcare provider if you have any signs or symptoms of pancreatitis including:
° nausea ° vomiting ° stomach-area (abdominal) pain
  • Liver problems. Liver problems, including death, can happen in people who take KALETRA. Your healthcare provider should do blood tests before and during your treatment with KALETRA to check your liver function. If you have Hepatitis B or Hepatitis C, or other liver problems, you may have an increased risk for developing new or worsening of liver problems during treatment with KALETRA. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including:
  • loss of appetite
  • yellow skin and whites of eyes (jaundice)
  • dark-colored urine
  • pale colored stools
  • itchy skin
  • stomach area (abdominal) pain
  • Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you:
    • have a history of abnormal heart rhythm or certain types of heart problems.
    • take other medicines that can affect your heart rhythm during treatment with KALETRA.

Tell your healthcare provider right away if you have any of these symptoms:

  • dizziness
  • lightheadedness
  • fainting
  • sensation of abnormal heartbeats
See “What are the possible side effects of KALETRA?” for more information about serious side effects.
What is KALETRA? KALETRA is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). It is not known if KALETRA is safe and effective in children under 14 days old.

Who should not take KALETRA?

Do not take KALETRA if you:
  • are allergic to lopinavir, ritonavir, or any of the ingredients in KALETRA. See the end of this Medication Guide for a complete list of ingredients in KALETRA.
  • if you take any of the following medicines:
    • alfuzosin
    • apalutamide
    • ranolazine
    • dronedarone
    • colchicine, if you have kidney or liver problems.
    • rifampin
    • lurasidone
    • pimozide
    • ergot containing medicines including:
      • dihydroergotamine mesylate
      • ergotamine tartrate
      • methylergonovine
    • cisapride
    • elbasvir/grazoprevir
    • lovastatin
    • simvastatin
    • lomitapide
    • sildenafil (Revatio ®), when used for the treatment of pulmonary arterial hypertension
    • triazolam
    • midazolam when taken by mouth
    • St. John’s Wort (Hypericum perforatum ®)

Serious problems can happen if you or your child takes any of the medicines listed above with KALETRA.

Before taking KALETRA, tell your healthcare provider about all of your medical conditions, including if you:

  • have ever had a serious skin rash or an allergic reaction to medicines that contain lopinavir or ritonavir.
  • have or had pancreas problems.
  • have liver problems, including Hepatitis B or Hepatitis C.
  • have any heart problems, including if you have a condition called Congenital Long QT Syndrome.
  • have low potassium in your blood.
  • have diabetes.
  • have high cholesterol in your blood.
  • have hemophilia. KALETRA may cause increased bleeding.
  • are pregnant or plan to become pregnant. It is not known if KALETRA will harm your unborn baby.
    • KALETRA oral solution contains alcohol (ethanol) and propylene glycol. You should not take KALETRA oral solution during pregnancy because there is no safe level of alcohol exposure during pregnancy. Tell your healthcare provider if you become pregnant during treatment with KALETRA.
    • KALETRA may reduce how well hormonal birth control works. Females who may become pregnant should use another effective form of birth control or an additional barrier method of birth control during treatment with KALETRA.
    • Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take KALETRA.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA.

Keep a list of your medicines to show your healthcare provider and pharmacist.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with KALETRA.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take KALETRA with other medicines. Your healthcare provider may need to change the dose of other medicines during treatment with KALETRA.

How should I take KALETRA?

  • Take KALETRA every day exactly as prescribed by your healthcare provider.
  • Stay under the care of your healthcare provider during treatment with KALETRA.
  • It is important to set up a dosing schedule and follow it every day.
  • Do not change your treatment or stop treatment without first talking with your healthcare provider.
  • Swallow KALETRA tablets whole. Do not chew, break, or crush KALETRA tablets.
  • KALETRA tablets can be taken with or without food.
  • KALETRA oral solution must be taken with food.
  • If you are taking both didanosine and KALETRA:
    • Didanosine can be taken at the same time as KALETRA tablets, without food.
    • Take didanosine either 1 hour before or 2 hours after taking KALETRA oral solution.
  • If you are pregnant:
    • You should not take KALETRA tablets on a 1 time each day dose schedule.
    • Avoid use of KALETRA oral solution.
  • If your child is prescribed KALETRA:
    • Tell your healthcare provider if your child’s weight changes.
  • KALETRA should not be given to children on a 1 time each day dose schedule. When giving KALETRA to your child, give KALETRA exactly as prescribed.
    • Use the dosing cup (supplied) or an oral syringe with mL (milliliter) markings to give the prescribed dose of KALETRA oral solution to your child. Your pharmacist should provide an oral syringe to you.
    • KALETRA oral solution contains propylene glycol and a large amount of alcohol (ethanol). KALETRA oral solution should not be given to babies younger than 14 days of age unless your healthcare provider thinks it is right for your baby.
  • Talk with your healthcare provider if you plan to take or give KALETRA oral solution through a feeding tube. KALETRA oral solution contains propylene glycol and alcohol (ethanol), and should not be used with certain feeding tubes.
  • You may have a greater chance of getting diarrhea if you take KALETRA 1 time each day than if you take it 2 times each day.
  • Do not miss a dose of KALETRA. This could make the virus harder to treat. If you forget to take KALETRA, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking your next dose at its regular time. Do not take more than one dose of KALETRA at one time.
  • If you or your child take more than the prescribed dose of KALETRA, call your healthcare provider or go to the nearest emergency room right away.
What are the possible side effects of KALETRA? KALETRA can cause serious side effects, including:
  • See “What is the most important information I should know about KALETRA?”
  • Diabetes and high blood sugar (hyperglycemia). You may develop new or worsening diabetes or high blood sugar during treatment with KALETRA. Tell your healthcare provider if you get any of the following signs or symptoms:
  • urinate more often than usual
  • increased hunger or thirst
  • unusual weight loss
  • increase in your blood sugar levels
  • Your healthcare provider may need to start you on medicine to treat high blood sugar or change your diabetes medicines.
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.
  • Increases in certain fat (triglycerides and cholesterol) levels in your blood. Large increases of triglycerides and cholesterol can be seen in blood test results of some people who take KALETRA. Your healthcare provider should do blood tests to check your cholesterol and triglyceride levels before you start taking KALETRA and during your treatment.
  • Changes in body fat can happen in some people who take antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known at this time.
  • Increased bleeding in people with hemophilia. Some people with hemophilia have increased bleeding with KALETRA or similar medicines.
  • Skin rash, which can be severe, can happen in people who take KALETRA. Tell your healthcare provider if you have a history of skin rash with other medicine used to treat your HIV-1 infection or if you get any skin rash during treatment with KALETRA.
  • Kidney stones

Common side effects of KALETRA include:

  • diarrhea
  • nausea
  • vomiting
  • increased fats in blood (triglycerides or cholesterol)

These are not all of the possible side effects of KALETRA. For more information, ask your healthcare provider or pharmacist.

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 KALETRA? KALETRA tablets:
  • Store KALETRA tablets at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Store KALETRA tablets in the original container.
  • Do not keep KALETRA tablets out of the container it comes in for longer than 2 weeks, especially in areas where there is a lot of humidity.
  • Keep the container closed tightly.
KALETRA oral solution:
  • Store KALETRA oral solution in a refrigerator, between 36°F to 46°F (2°C to 8°C). KALETRA oral solution that is kept refrigerated may be used until the expiration date printed on the label.
  • KALETRA oral solution that is stored at room temperature (less than 77°F or 25°C) should be used within 2 months.
  • Keep KALETRA oral solution away from high heat.
  • Throw away any medicine that is out of date or that you no longer need.

Keep KALETRA and all medicines out of the reach of children.

General information about the safe and effective use of KALETRA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KALETRA for a condition for which it was not prescribed. Do not give KALETRA to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KALETRA that is written for health professionals.
What are the ingredients in KALETRA? Active ingredients: lopinavir and ritonavir Inactive ingredients: KALETRA 200 mg lopinavir and 50 mg ritonavir yellow tablets: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The film coating contains: colloidal silicone dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, titanium dioxide, and yellow ferric oxide E172. KALETRA 200 mg lopinavir and 50 mg ritonavir red tablets: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The film coating contains: colloidal silicone dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, titanium dioxide, and red ferric oxide E172. KALETRA 100 mg lopinavir and 25 mg ritonavir pale yellow tablets: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The film coating contains: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, and yellow ferric oxide E172. KALETRA 100 mg lopinavir and 25 mg ritonavir pink tablets: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The film coating contains: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, and red ferric oxide E172. KALETRA oral solution: acesulfame potassium, artificial cotton candy flavor, citric acid, ethanol (a type of alcohol), glycerin, high fructose corn syrup, Magnasweet-110 flavor, menthol, natural and artificial vanilla flavor, peppermint oil, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, saccharin sodium, sodium chloride, sodium citrate, and water. KALETRA oral solution contains approximately 42% ethanol (a type of alcohol) and approximately 15% propylene glycol. “See How should I take KALETRA?” For more information about KALETRA call 1-800-633-9110 or go to www.KALETRA.com Manufactured by AbbVie Inc., North Chicago, IL 60064 USA KALETRA is a trademark of AbbVie Inc. © 2020 AbbVie Inc. All rights reserved. The brands listed are trademarks of their respective owners and are not trademarks of AbbVie Inc. The makers of these brands are not affiliated with and do not endorse AbbVie Inc. or its products. 20065455

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: October 2020

PDP
(click image for full-size original)

KALETRA lopinavir and ritonavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2348(NDC:0074-6799)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPINAVIR (LOPINAVIR) LOPINAVIR 200 mg
RITONAVIR (RITONAVIR) RITONAVIR 50 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31
SORBITAN MONOLAURATE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
TALC
POLYETHYLENE GLYCOL 3350
FERRIC OXIDE YELLOW
POLYSORBATE 80
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 19mm
Flavor Imprint Code a;KA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2348-2 12 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021906 06/18/2010
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2348)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.

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