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Details for New Drug Application (NDA): 077661

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NDA 077661 describes GABAPENTIN, which is a drug marketed by Sciegen Pharms Inc, Alkem Labs Ltd, Acella Pharms Llc, Invagen Pharms, Ranbaxy, Sun Pharm Inds Ltd, Marksans Pharma, Ivax Sub Teva Pharms, Sandoz, Amneal Pharms, Zydus Pharms Usa Inc, Teva, Amneal Pharms Ny, Teva Pharms, Mylan Pharms Inc, Sun Pharm Inds, Aci Healthcare Ltd, Actavis Elizabeth, Hikma, Aurobindo Pharma Ltd, Alkem, Mylan, Apotex Inc, Taro, Glenmark Generics, Hi Tech Pharma, Hikma Pharms, Watson Labs, Tris Pharma Inc, and Aurobindo Pharm, and is included in forty-two NDAs. It is available from ninety-five suppliers. Additional details are available on the GABAPENTIN profile page.

The generic ingredient in GABAPENTIN is gabapentin. There are twenty-six drug master file entries for this compound. Ninety-eight suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 077661

Apotex Inc
Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 077661

Suppliers and Packaging for NDA: 077661

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 077661 ANDA Golden State Medical Supply, Inc. 60429-782 60429-782-01 100 TABLET, FILM COATED in 1 BOTTLE (60429-782-01)
TABLET;ORAL 077661 ANDA Golden State Medical Supply, Inc. 60429-782 60429-782-05 500 TABLET, FILM COATED in 1 BOTTLE (60429-782-05)

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Sep 13, 2006TE:ABRLD:No

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Sep 13, 2006TE:ABRLD:No

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