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Generated: October 21, 2018

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Details for New Drug Application (NDA): 077795

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NDA 077795 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 077795
Tradename:OXCARBAZEPINE
Applicant:West-ward Pharms Int
Ingredient:oxcarbazepine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077795
Suppliers and Packaging for NDA: 077795
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077795 ANDA West-Ward Pharmaceticals Corp. 0054-0097 0054-0097-20 10 BLISTER PACK in 1 BOX (0054-0097-20) > 10 TABLET in 1 BLISTER PACK
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077795 ANDA West-Ward Pharmaceticals Corp. 0054-0097 0054-0097-25 100 TABLET in 1 BOTTLE (0054-0097-25)

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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