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Details for New Drug Application (NDA): 202961

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NDA 202961 describes OXCARBAZEPINE, which is a drug marketed by Taro, Glenmark Generics, Ani Pharms Inc, Sun Pharm Inds Ltd, Cadista Pharms, Apotex Inc, Amneal Pharms, Breckenridge Pharm, Roxane, and Sun Pharm Inds, and is included in eleven NDAs. It is available from twenty-four suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for NDA: 202961

Tradename:
OXCARBAZEPINE
Applicant:
Amneal Pharms
Ingredient:
oxcarbazepine
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 202961

Suppliers and Packaging for NDA: 202961

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE
oxcarbazepine
SUSPENSION;ORAL 202961 ANDA Amneal Pharmaceuticals of New York, LLC 65162-649 65162-649-78 1 BOTTLE in 1 CARTON (65162-649-78) > 250 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:Sep 17, 2012TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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