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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Accenture
Express Scripts
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Colorcon
Federal Trade Commission
US Department of Justice
Healthtrust
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Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205101

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NDA 205101 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 205101

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

Pharmacology for NDA: 205101

Suppliers and Packaging for NDA: 205101

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN
gabapentin
TABLET;ORAL 205101 ANDA Atlantic Biologicals Corps 17856-0135 17856-0135-1 100 DOSE PACK in 1 CONTAINER (17856-0135-1) > 1 mg in 1 DOSE PACK
GABAPENTIN
gabapentin
TABLET;ORAL 205101 ANDA PD-Rx Pharmaceuticals, Inc. 43063-756 43063-756-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-756-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 4, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Feb 4, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
Argus Health
Cipla
Fuji
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Fish and Richardson
Moodys
US Army
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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