CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Chlordiazepoxide Hydrochloride and Clidinium Bromide by

Drug Labeling and Warnings

Chlordiazepoxide Hydrochloride and Clidinium Bromide by is a Prescription medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Inc., Dr. Reddy's Laboratories Limited - FTO SEZ Process Unit -01. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • ADVERSE REACTIONS:

    No side effects or manifestations not seen with either compound alone have been reported with the administration of chlordiazepoxide hydrochloride and clidinium bromide capsules. However, since chlordiazepoxide hydrochloride and clidinium bromide capsules contains chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded.

    When chlordiazepoxide hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients — particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

    Other adverse reactions reported during therapy with chlordiazepoxide hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide hydrochloride treatment.

    Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable.

    Adverse effects reported with use of chlordiazepoxide hydrochloride and clidinium bromide capsules are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when chlordiazepoxide hydrochloride and clidinium bromide therapy has been combined with other spasmolytic agents and/or a low residue diet.

    To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DRUG ABUSE AND DEPENDENCE:

    Controlled Substance

    Chlordiazepoxide hydrochloride and clidinium bromide capsules contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide hydrochloride and clidinium bromide capsules is exempted from Schedule IV and is not controlled under the Controlled Substances Act.

    Abuse

    Chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, is a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.

    Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS).

    The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).

    Dependence

    Physical Dependence

    Chlordiazepoxide hydrochloride and clidinium bromide capsules may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS).

    To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage (see WARNINGS and DOSAGE AND ADMINISTRATION).

    Acute Withdrawal Signs and Symptoms

    Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality.

    Protracted Withdrawal Syndrome

    Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.

    Tolerance

    Tolerance to chlordiazepoxide hydrochloride and clidinium bromide capsules may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effects of chlordiazepoxide hydrochloride and clidinium bromide capsules may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

  • OVERDOSAGE

    Overdosage of Librax, which contains a benzodiazepine (chlordiazepoxide hydrochloride) and an anticholinergic (clidinium bromide) may manifest signs and symptoms related to either of its components, although some effects such as altered levels of consciousness may be synergistic. Overdosage of benzodiazepines, such as chlordiazepoxide hydrochloride, is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma.

    Signs and symptoms of anticholinergic overdosage are related to excessive anti-muscarinic anticholinergic activity. Peripheral signs and symptoms may include dry mucous membranes and skin, flushing, tachycardia, hypertension, ileus, urinary retention, and mydriasis. Garbled speech is often pathognomonic. Central signs and symptoms may include agitation and delirium, seizures, and hyperthermia. Benzodiazepines are considered a first-line treatment for anticholinergic toxicity acting to treat mild to moderate agitation and prevent seizures.

    Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS, Dependence and Withdrawal Reactions). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. Anticholinergic drugs usually increase heart rate and blood pressure. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids, and airway management.

    Flumazenil, a specific benzodiazepine receptor antagonist is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage. Use of flumazenil may increase the risk of seizures in mixed overdosage with drugs that may precipitate seizures, including anticholinergic medications. Benzodiazepines are used to treat agitated delirium from anticholinergic toxicity. Therefore flumazenil administration may worsen the anticholinergic delirium and should generally be avoided.

    Anticholinesterase inhibitors may reverse severe agitated delirium that is not controlled by benzodiazepines. They may also improve the airway and breathing in CNS depressed patients. Caution is warranted especially in mixed drug overdoses.

    Consider contacting a poison center (1-800-222-1222) or a medical toxicologist for overdosage management recommendations.

  • DOSAGE AND ADMINISTRATION:

    Recommended Dosage

    Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of chlordiazepoxide hydrochloride and clidinium bromide capsules varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

    Recommended Geriatric Dosage

    Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 chlordiazepoxide hydrochloride and clidinium bromide capsules per day, to be increased gradually as needed and tolerated. Elderly patients have an increased risk of dose-related adverse reactions (see PRECAUTIONS).

    Discontinuation or Dosage Reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules

    To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS and DRUG ABUSE AND DEPENDENCE).

  • HOW SUPPLIED:

    Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg are available in hard gelatin capsules with light blue cap and dark blue body, imprinted “RDY” on cap and “706” on body with black ink and are free from physical defects. These are supplied in bottles of 100’s and 500’s.

    Bottles of 100 NDC: 43598-706-01

    Bottles of 500 NDC: 43598-706-05

    Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

    Keep out of reach of children.

    Dispense in tight, light-resistant container as defined in USP/NF.

    Rx Only

    Distributor:

    Dr. Reddy’s Laboratories Inc.,

    Princeton, NJ 08540 USA

    Made in India

    Revised: 05/2023

  • MEDICATION GUIDE

    MEDICATION GUIDE
    Chlordiazepoxide Hydrochloride and C    lidinium Bromide
    (    klor” dye az” e pox’ ide hye” droe klor’ ide and kli din’ ee um broe’ mide)Capsules, USP
    for oral use
    What is the most important information I should know about chlordiazepoxide hydrochloride and clidinium bromide capsules?
    • Chlordiazepoxide hydrochloride and clidinium bromide capsules contains a benzodiazepine medicine. Taking chlordiazepoxide hydrochloride and clidinium bromide capsules with opioid medicines, alcohol, or other centralnervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
      • shallow or slowed breathing
      • breathing stops (which may lead to the heart stopping)
      • excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking chlordiazepoxide hydrochloride and clidinium bromide capsules with opioids affects you.
    • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules, which can lead to overdose or death.
      • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
      • You can develop an addiction even if you take chlordiazepoxide hydrochloride and clidinium bromide capsules as prescribed by your healthcare provider.
      • Take chlordiazepoxide hydrochloride and clidinium bromide capsules exactly as your healthcare provider prescribed.
      • Do not share your chlordiazepoxide hydrochloride and clidinium bromide capsules with other people.
      • Keep chlordiazepoxide hydrochloride and clidinium bromide capsules in a safe place and away from children.
    • Physical dependence and withdrawal reactions. Chlordiazepoxide hydrochloride and clidinium bromide capsules can cause physical dependence and withdrawal reactions.
      • Do not suddenly stop using chlordiazepoxide hydrochloride and clidinium bromide capsules. Stopping chlordiazepoxide hydrochloride and clidinium bromide capsules suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
      • Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitches, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
      • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
      • Do not take more chlordiazepoxide hydrochloride and clidinium bromide capsules than prescribed or take chlordiazepoxide hydrochloride and clidinium bromide capsules for longer than prescribed. 
    What are chlordiazepoxide hydrochloride and clidinium bromide capsules?
    • Chlordiazepoxide hydrochloride and clidinium bromide capsules are prescription medicine that are used with other therapies for the treatment of:
      • stomach (peptic) ulcers
      • irritable bowel syndrome (IBS)
      • inflammation of the colon called acute enterocolitis
    • Chlordiazepoxide hydrochloride and clidinium bromide capsules contains the medicines chlordiazepoxide hydrochloride and clidinium bromide.
    • Chlordiazepoxide hydrochloride and clidinium bromide capsulescontains chlordiazepoxide hydrochloride that can be abused or lead to dependence. Keep chlordiazepoxide hydrochloride and clidinium bromide capsules in a safe place to prevent misuse and abuse. Selling or giving away chlordiazepoxide hydrochloride and clidinium bromide capsules may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
    • It is not known if chlordiazepoxide hydrochloride and clidinium bromide capsules are safe and effective in children.

    Do not take chlordiazepoxide hydrochloride and clidinium bromide capsules if you:
    • have glaucoma
    • have an enlarged prostate
    • have a blockage of your bladder that causes problems with urination
    • are allergic to chlordiazepoxide hydrochloride or clidinium bromide
    Before you take chlordiazepoxide hydrochloride and clidinium bromide capsules, tell your healthcare provider about all of your medical conditions, including if you:
    • have eye problems
    • have problems urinating or emptying your bladder
    • have coordination problems
    • have kidney or liver problems
    • have a history of depression, mental illness, or suicidal thoughts
    • have a history of drug or alcohol abuse or addiction
    • have bleeding problems
    • are pregnant or plan to become pregnant. Chlordiazepoxide hydrochloride and clidinium bromide capsules may harm your unborn baby.
    • taking chlordiazepoxide hydrochloride and clidinium bromide capsules may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness irritability, restlessness, shaking, excessive crying, feeding problems).
    • may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
    • are breastfeeding or plan to breastfeed. Chlordiazepoxide hydrochloride and clidinium bromide may pass through your breast milk and may cause sedation, poor feeding or poor weight gain in your baby. Talk to your healthcare provider about the best way to feed your baby if you take chlordiazepoxide hydrochloride and clidinium bromide capsules. Chlordiazepoxide hydrochloride and clidinium bromide capsules may decrease the amount of breast milk your body makes.
    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    Taking chlordiazepoxide hydrochloride and clidinium bromide capsules with certain other medicines can cause side effects or affect how well chlordiazepoxide hydrochloride and clidinium bromide capsules or the other medicines work.
    Do not start or stop other medicines without talking to your healthcare provider.
    Especially tell your healthcare provider if you:
    • take a monoamine oxidase inhibitor (MAOI) medicine or an anti-psychotic medicine called phenothiazine.
    How should I take chlordiazepoxide hydrochloride and clidinium bromide capsules?
    • Take chlordiazepoxide hydrochloride and clidinium bromide capsules exactly as your healthcare provider tells you to take it.
    • Your healthcare provider may change your dose of chlordiazepoxide hydrochloride and clidinium bromide capsules if needed. Do not change your dose of chlordiazepoxide hydrochloride and clidinium bromide capsules or suddenly stop taking chlordiazepoxide hydrochloride and clidinium bromide capsules without talking with your healthcare provider.
    • If you take too much chlordiazepoxide hydrochloride and clidinium bromide capsules, call your healthcare provider or go to the nearest hospital emergency room right away.
    What are the possible side effects of chlordiazepoxide hydrochloride and clidinium bromide capsules?
    Chlordiazepoxide hydrochloride and clidinium bromide capsules may cause serious side effects, including: See “What is the most important information I should know about chlordiazepoxide hydrochloride and clidinium bromide capsules?”
    • Chlordiazepoxide hydrochloride and clidinium bromide capsules can make you sleepy or dizzy and can slow your thinking and motor skills.
      • Do not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide hydrochloride and clidinium bromide capsules affects you.
      • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide hydrochloride and clidinium bromide capsules without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide hydrochloride and clidinium bromide capsules may make your sleepiness or dizziness much worse. 
    The most common side effects of chlordiazepoxide hydrochloride and clidinium bromide capsules include:
    • dry mouth
    • nausea
    • skin problems
    • blurred vision
    • constipation
    • swelling
    • irregular menstrual (periods) cycles
    • increase and decreased desire for sex (libido)
    • problems starting to urinate
    • drowsiness, coordination problems, and confusion may happen, especially in people who are elderly or weak
    These are not all the possible side effects of chlordiazepoxide hydrochloride and clidinium bromide capsules.
    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 chlordiazepoxide hydrochloride and clidinium bromide capsules?
    • Store chlordiazepoxide hydrochloride and clidinium bromide capsules at room temperature 77°F (25°C).
    • Keep chlordiazepoxide hydrochloride and clidinium bromide capsules and all medicines out of the reach of children.
    General information about the safe and effective use of chlordiazepoxide hydrochloride and clidinium bromide capsules.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take chlordiazepoxide hydrochloride and clidinium bromide capsules for a condition for which it was not prescribed. Do not give chlordiazepoxide hydrochloride and clidinium bromide capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about chlordiazepoxide hydrochloride and clidinium bromide capsules that is written for health professionals.
    What are the ingredients in chlordiazepoxide hydrochloride and clidinium bromide capsules?
    Active ingredients:     chlordiazepoxide hydrochloride and clidinium bromide
    Inactive ingredients:    lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate and talc.
    Each capsule shell contains: FD&C Blue 1, gelatin and titanium dioxide.
    The capsule shells are imprinted with black ink. The black ink contains, black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

    Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 USA
    Made in India

    For more information, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784.

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

    To reorder additional Medication Guides, contact Dr. Reddy’s Customer Service at 1-866-733-3952.

    Revised: 05/2023

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

    Container Label:

    Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number. container1

  • INGREDIENTS AND APPEARANCE
    CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 
    chlordiazepoxide hydrochloride and clidinium bromide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43598-706
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlordiazepoxide Hydrochloride (UNII: MFM6K1XWDK) (Chlordiazepoxide - UNII:6RZ6XEZ3CR) Chlordiazepoxide Hydrochloride5 mg
    Clidinium Bromide (UNII: 91ZQW5JF1Z) (Clidinium - UNII:BO76JF850N) Clidinium Bromide2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Low-Substituted Hydroxypropyl Cellulose, Unspecified (UNII: 2165RE0K14)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Talc (UNII: 7SEV7J4R1U)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Gelatin, Unspecified (UNII: 2G86QN327L)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Shellac (UNII: 46N107B71O)  
    Ammonia (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorBLUE (light blue cap and dark blue body) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code RDY;706
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43598-706-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/10/2021
    2NDC: 43598-706-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21469805/10/2021
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Limited - FTO SEZ Process Unit -01860037244analysis(43598-706) , manufacture(43598-706)
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