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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Fuji
Teva
Cipla
Fish and Richardson
McKinsey
Argus Health
Baxter
Dow
QuintilesIMS

Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090335

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NDA 090335 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, Teva Pharms Usa, 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 Pharm, Glenmark Pharms Ltd, Taro, Hi Tech Pharma, Hikma Pharms, Watson Labs, Tris Pharma Inc, and Epic Pharma Llc, and is included in forty-four NDAs. It is available from one hundred and two 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. One hundred and five suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 090335

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 090335

Suppliers and Packaging for NDA: 090335

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN
gabapentin
TABLET;ORAL 090335 ANDA Mylan Pharmaceuticals Inc. 0378-5424 0378-5424-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-5424-01)
GABAPENTIN
gabapentin
TABLET;ORAL 090335 ANDA Mylan Pharmaceuticals Inc. 0378-5424 0378-5424-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-5424-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jun 1, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jun 1, 2010TE:ABRLD:No


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