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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 202961


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NDA 202961 describes OXCARBAZEPINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Kanchan Hlthcare, Renew Pharms, Rubicon, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-five NDAs. It is available from thirty-three 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. Thirty-six 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
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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