Ciprofloxacin (Page 11 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is available in 200 mg and 400 mg strengths supplied in flexible containers as follows:

Ciprofloxacin Injection, USP in
NDC 5% Dextrose (2 mg per mL) Package Factor
25021-114-82 200 mg per 100 mL single-dose 24 bags per carton
flexible container bag
25021-114-87 400 mg per 200 mL single-dose 24 bags per carton
flexible container bag

Ciprofloxacin Injection, USP (ciprofloxacin) is available as a clear, colorless to slightly yellowish solution.

Storage Conditions

Store between 5° and 25°C (41° and 77°F).

Protect from light. Avoid excessive heat. Protect from freezing.

Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container and container closure are not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

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

Serious Adverse Reactions

Advise patients to stop taking ciprofloxacin if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.

Inform patients of the following serious adverse reactions that have been associated with ciprofloxacin or other fluoroquinolone use:

  • Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of ciprofloxacin and may occur together in the same patient. Inform patients to stop taking ciprofloxacin immediately if they experience an adverse reaction and to call their healthcare provider.
  • Tendon Disorders: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue ciprofloxacin treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
  • Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with ciprofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue ciprofloxacin and tell them to contact their physician.
  • Central nervous system effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including ciprofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to ciprofloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.
  • Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.
  • Hypersensitivity Reactions: Inform patients that ciprofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
  • Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking ciprofloxacin. Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.
  • Aortic Aneurysm and Dissection: Inform patients to seek emergency medical care if they experience sudden chest, stomach, or back pain.
  • Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.
  • Prolongation of the QT Interval: Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physician if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.
  • Musculoskeletal Disorders in Pediatric Patients: Instruct parents to inform their child’s physician if the child has a history of joint-related problems before taking this drug. Inform parents of pediatric patients to notify their child’s physician of any joint-related problems that occur during or following ciprofloxacin therapy [see Warnings and Precautions (5.13) and Use in Specific Populations (8.4)].
  • Tizanidine: Instruct patients not to use ciprofloxacin if they are already taking tizanidine. Ciprofloxacin increases the effects of tizanidine (Zanaflex®).
  • Theophylline: Inform patients that ciprofloxacin may increase the effects of theophylline. Life-threatening CNS effects and arrhythmias can occur. Advise the patients to immediately seek medical help if they experience seizures, palpitations, or difficulty breathing.
  • Caffeine: Inform patients that ciprofloxacin may increase the effects of caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
  • Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Inform patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, instruct them to wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, instruct patients to contact their physician.
  • Blood Glucose Disturbances: Inform the patients that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue ciprofloxacin and consult a physician.
  • Lactation: For indications other than inhalational anthrax (post-exposure), advise a woman that breastfeeding is not recommended during treatment with ciprofloxacin and for an additional 2 days after the last dose. Alternatively, a woman may pump and discard during treatment and for additional 2 days after the last dose [see Use in Specific Populations (8.2)].

Antibacterial Resistance

Inform patients that antibacterial drugs including ciprofloxacin should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When ciprofloxacin prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ciprofloxacin or other antibacterial drugs in the future.

Administration

Inform patients to drink fluids liberally while taking ciprofloxacin to avoid formation of highly concentrated urine and crystal formation in the urine.

Drug Interactions Oral Antidiabetic Agents

Inform patients that hypoglycemia has been reported when ciprofloxacin and oral antidiabetic agents were co-administered; if low blood sugar occurs with ciprofloxacin, instruct them to consult their physician and that their antibacterial medicine may need to be changed.

Anthrax and Plague Studies

Inform patients given ciprofloxacin for this condition that efficacy studies could not be conducted in humans for ethical and feasibility reasons. Therefore, approval for these conditions was based on efficacy studies conducted in animals.

Brands listed are the trademarks of their respective owners.

SAGENT®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Switzerland©2020 Sagent Pharmaceuticals, Inc.

Revised: August 2020

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

MEDICATION GUIDE CIPROFLOXACIN (sip-row-FLOX-a-sin) INJECTION, USP (in 5% Dextrose Injection)(ciprofloxacin)for intravenous infusion
Read this Medication Guide before you start taking ciprofloxacin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about ciprofloxacin? Ciprofloxacin, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you get any of the following serious side effects while you take ciprofloxacin, you should stop taking ciprofloxacin immediately and get medical help right away.

  1. Tendon rupture or swelling of the tendon (tendinitis).
    • Tendon problems can happen in people of all ages who take ciprofloxacin. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
      • pain
      • swelling
      • tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites.
    • The risk of getting tendon problems while you take ciprofloxacin is higher if you:
      • are over 60 years of age
      • are taking steroids (corticosteroids)
      • have had a kidney, heart or lung transplant.
    • Tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin.
    • Other reasons that can increase your risk of tendon problems can include:
      • physical activity or exercise
      • kidney failure
      • tendon problems in the past, such as in people with rheumatoid arthritis (RA).
    • Stop taking ciprofloxacin immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.
    • Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin. Tendon ruptures can happen within hours or days of taking ciprofloxacin and have happened up to several months after people have finished taking their fluoroquinolone.
    • Stop taking ciprofloxacin immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
      • hear or feel a snap or pop in a tendon area
      • bruising right after an injury in a tendon area
      • unable to move the affected area or bear weight

    The tendon problems may be permanent.

  2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin. Stop taking ciprofloxacin immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
    • pain
    • burning
    • tingling
    • numbness
    • weakness

    Ciprofloxacin may need to be stopped to prevent permanent nerve damage.

  3. Central Nervous System (CNS) effects. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin. Tell your healthcare provider if you have a history of seizures before you start taking ciprofloxacin. CNS side effects may happen as soon as after taking the first dose of ciprofloxacin. Stop taking ciprofloxacin immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
    • seizures
    • hear voices, see things, or sense things that are not there (hallucinations)
    • feel restless or agitated
    • tremors
    • feel anxious or nervous
    • confusion
    • depression
    • reduced awareness of surroundings
    • trouble sleeping
    • nightmares
    • feel lightheaded or dizzy
    • feel more suspicious (paranoia)
    • suicidal thoughts or acts
    • headaches that will not go away, with or without blurred vision
    • memory problems
    • false or strange thoughts or beliefs (delusions)

    The CNS changes may be permanent.

  4. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking ciprofloxacin. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
What is ciprofloxacin? Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
  • urinary tract infection
  • chronic prostate infection
  • lower respiratory tract infection
  • sinus infection
  • skin infection
  • bone and joint infection
  • nosocomial pneumonia
  • intra-abdominal infection, complicated
  • infectious diarrhea
  • typhoid (enteric) fever
  • cervical and urethral gonorrhea, uncomplicated
  • people with a low white blood cell count and a fever
  • inhalational anthrax
  • plague
  • Studies of ciprofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
  • Ciprofloxacin should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
  • Ciprofloxacin should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections caused by a certain type of bacterial called Streptococcus pneumoniae.
  • Ciprofloxacin Injection, USP is also used in children younger than 18 years of age to treat complicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs.
  • Children younger than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ciprofloxacin. Ciprofloxacin should not be used as the first choice of antibacterial medicine in children under 18 years of age.
Who should not take ciprofloxacin? Do not take ciprofloxacin if you:
  • have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolone, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin. See the end of this Medication Guide for a complete list of ingredients in ciprofloxacin.
  • also take a medicine called tizanidine (Zanaflex®).
Ask your healthcare provider if you are not sure.
What should I tell my healthcare provider before taking ciprofloxacin? Before you take ciprofloxacin, tell your healthcare provider about all your medical conditions, including if you:
  • have tendon problems; ciprofloxacin should not be used in patients who have a history of tendon problems.
  • have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin should not be used in patients who have a known history of myasthenia gravis
  • have liver problems
  • have central nervous system problems (such as epilepsy).
  • have nerve problems. Ciprofloxacin should not be used in patients who have a history of a nerve problem called peripheral neuropathy
  • have or anyone in your family has an irregular heartbeat, or heart attack, especially a condition called “QT prolongation”.
  • have low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).
  • have or have had seizures.
  • have kidney problems. You may need a lower dose of ciprofloxacin if your kidneys do not work well.
  • have diabetes or problems with low blood sugar (hypoglycemia).
  • have joint problems including rheumatoid arthritis (RA)
  • have trouble swallowing pills.
  • are pregnant or plan to become pregnant. It is not known if ciprofloxacin will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Ciprofloxacin passes into your breast milk.
    • You should not breastfeed during treatment with ciprofloxacin and for 2 days after taking your last dose of ciprofloxacin. You may pump your breast milk and throw it away during treatment with ciprofloxacin and for 2 days after taking your last dose of ciprofloxacin.
    • If you are taking ciprofloxacin for inhalation anthrax, you and your healthcare provider should decide whether you can continue breastfeeding while taking ciprofloxacin.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Ciprofloxacin and other medicines can affect each other causing side effects.
  • Especially tell your healthcare provider if you take:
    • a steroid medicine.
    • an anti-psychotic medicine.
    • a tricyclic antidepressant.
    • a water pill (diuretic).
    • theophylline (such as Theo-24® , Elixophyllin® , Theochron® , Uniphyl® , Theolair®).
    • a medicine to control your heart rate or rhythm (antiarrhythmics).
    • an oral anti-diabetes medicine.
    • phenytoin (Fosphenytoin Sodium® , Cerebyx® , Dilantin-125® , Dilantin® , Extended Phenytoin Sodium® , Prompt Phenytoin Sodium® , Phenytek®).
    • cyclosporine (Gengraf® , Neoral® , Sandimmune® , Sangcya®).
    • a blood thinner (such as warfarin, Coumadin® , Jantoven®).
    • methotrexate (Trexall®).
    • ropinirole (Requip®).
    • clozapine (Clozaril® , Fazaclo® ODT®).
    • a Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
    • sildenafil (Viagra® , Revatio®).
    • duloxetine.
    • products that contain caffeine.
    • probenecid (Probalan® , Col-probenecid®).
Ask your healthcare provider for a list of these medicines if you are not sure.Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ciprofloxacin?
Taking all of your ciprofloxacin doses will help make sure that all of the bacteria are killed. Taking all of your ciprofloxacin doses will help lower the chance that the bacteria will become resistant to ciprofloxacin. If you become resistant to ciprofloxacin, ciprofloxacin and other antibacterial medicines may not work for you in the future.
  • If you take too much ciprofloxacin, call your healthcare provider or get medical help right away.

What should I avoid while taking ciprofloxacin?

  • Ciprofloxacin can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin affects you.
  • Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get a severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take ciprofloxacin, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of ciprofloxacin? Ciprofloxacin may cause serious side effects, including:

  • See What is the most important information I should know about ciprofloxacin?
  • Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin, even after only 1 dose. Stop taking ciprofloxacin and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
    • hives
    • trouble breathing or swallowing
    • swelling of the lips, tongue, face
    • throat tightness, hoarseness
    • rapid heartbeat
    • faint
    • skin rash

    Skin rash may happen in people taking ciprofloxacin even after only 1 dose. Stop taking ciprofloxacin at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ciprofloxacin.

  • Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ciprofloxacin. Call your healthcare provider right away if you have unexplained symptoms such as:
    • nausea or vomiting
    • stomach pain
    • fever
    • weakness
    • abdominal pain or tenderness
    • itching
    • unusual tiredness
    • loss of appetite
    • light colored bowel movements
    • dark colored urine
    • yellowing of the skin and whites of your eyes
Stop taking ciprofloxacin and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin (a liver problem).
  • Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.
  • Intestine infection ( Clostridioides difficile – associated diarrhea). Clostridioides difficile -associated diarrhea (CDAD) can happen with many antibacterial medicines, including ciprofloxacin. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. CDAD can happen 2 or more months after you have finished your antibacterial medicine.
  • Serious heart rhythm changes (QT prolongation and torsade de pointes). Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:
    • who are elderly.
    • with a family history of prolonged QT interval.
    • with low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).
    • who take certain medicines to control heart rhythm (antiarrhythmics).
  • Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18 years old can happen. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin.
  • Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking ciprofloxacin?
  • Changes in blood sugar. People who take ciprofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking ciprofloxacin, stop taking ciprofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.
The most common side effects of ciprofloxacin include:
  • nausea
  • diarrhea
  • changes in liver function tests
  • vomiting
  • rash
Tell your healthcare provider about any side effect that bothers you, or that does not go away.These are not all the possible side effects of ciprofloxacin. 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.
Keep ciprofloxacin and all medicines out of the reach of children.
General Information about the safe and effective use of ciprofloxacin. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ciprofloxacin for a condition for which it is not prescribed. Do not give ciprofloxacin to other people, even if they have the same symptoms that you have. It may harm them.This Medication Guide summarizes the most important information about ciprofloxacin. If you would like more information about ciprofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin that is written for healthcare professionals.
What are the ingredients in ciprofloxacin? Ciprofloxacin Injection, USP (in 5% Dextrose Injection):
  • Active ingredient: ciprofloxacin
  • Inactive ingredients: dextrose monohydrate as a tonicity agent, hydrochloric acid for pH adjustment, lactic acid as a solubilizing agent.
Brands listed are the trademarks of their respective owners.SAGENT® Mfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA)Made in Switzerland©2020 Sagent Pharmaceuticals, Inc.Revised: August 2020

SAGENT Pharmaceuticals®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL –Bag Label

NDC 25021-114-82

100 mL

Ciprofloxacin Injection, USP

200 mg

2 mg/mL

5% Dextrose

200 mg in 100 mL 5% Dextrose

Rx only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL –Bag Label
(click image for full-size original)
CIPROFLOXACIN ciprofloxacin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-114
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ciprofloxacin (ciprofloxacin) ciprofloxacin 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
dextrose monohydrate
lactic acid, unspecified form
hydrochloric acid
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25021-114-82 24 POUCH in 1 CARTON contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CARTON (25021-114-82) and contains a BAG
1 100 mL in 1 BAG This package is contained within a POUCH and a CARTON (25021-114-82)
2 NDC:25021-114-87 24 POUCH in 1 CARTON contains a POUCH
2 1 BAG in 1 POUCH This package is contained within the CARTON (25021-114-87) and contains a BAG
2 200 mL in 1 BAG This package is contained within a POUCH and a CARTON (25021-114-87)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078252 03/24/2008
Labeler — Sagent Pharmaceuticals (796852890)

Revised: 08/2020 Sagent Pharmaceuticals

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