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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077802


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NDA 077802 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 077802
Tradename:OXCARBAZEPINE
Applicant:Glenmark Pharms Ltd
Ingredient:oxcarbazepine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077802
Suppliers and Packaging for NDA: 077802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077802 ANDA NuCare Pharmaceuticals,Inc. 68071-2973 68071-2973-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-2973-9)
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077802 ANDA Glenmark Pharmaceuticals Inc., USA 68462-137 68462-137-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-137-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 9, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 9, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Oct 9, 2007TE:ABRLD:No

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