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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Julphar
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Dow
Healthtrust
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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076403

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NDA 076403 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 four suppliers. Additional details are available on the GABAPENTIN profile page.

The generic ingredient in GABAPENTIN is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and seven suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 076403

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

Pharmacology for NDA: 076403

Suppliers and Packaging for NDA: 076403

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN
gabapentin
SOLUTION;ORAL 076403 ANDA Acella Pharmaceuticals, LLC 42192-608 42192-608-16 470 mL in 1 BOTTLE (42192-608-16)
GABAPENTIN
gabapentin
SOLUTION;ORAL 076403 ANDA Kiel Laboratories, Inc. 59063-127 59063-127-47 470 mL in 1 BOTTLE (59063-127-47)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/5ML
Approval Date:May 1, 2012TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Mallinckrodt
Cerilliant
QuintilesIMS
Express Scripts
Argus Health
US Army
Novartis
Moodys
UBS

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