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Generated: October 23, 2018

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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 Amneal Pharms, Sun Pharm Inds Ltd, West-ward Pharms Int, Ani Pharms Inc, Apotex Inc, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, and Taro, and is included in eleven NDAs. It is available from twenty-one suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 202961
Tradename:OXCARBAZEPINE
Applicant:Amneal Pharms
Ingredient:oxcarbazepine
Patents:0
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 LLC 65162-649 65162-649-78 1 BOTTLE in 1 CARTON (65162-649-78) > 250 mL in 1 BOTTLE
OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 202961 ANDA Precision Dose, Inc. 68094-123 68094-123-62 3 TRAY in 1 CASE (68094-123-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)

Profile for product number 001

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

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