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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202961


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NDA 202961 describes OXCARBAZEPINE, which is a drug marketed by Amneal Pharms, Aucta, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Renew Pharms, Rubicon, Sun Pharm Inds Ltd, Apotex, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty 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 twenty-one drug master file entries for this compound. Twenty-seven 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 AvPAK 50268-649 50268-649-30 30 CUP, UNIT-DOSE in 1 TRAY (50268-649-30) / 5 mL in 1 CUP, UNIT-DOSE (50268-649-05)
OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 202961 ANDA Amneal Pharmaceuticals LLC 65162-649 65162-649-48 10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)

Profile for product number 001

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

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