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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Healthtrust
Fish and Richardson
Merck
Express Scripts
Daiichi Sankyo
Boehringer Ingelheim
Baxter
Federal Trade Commission
Accenture

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075360

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NDA 075360 describes GABAPENTIN, which is a drug marketed by Actavis Elizabeth, Alkem, Amneal Pharms Ny, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Epic Pharma Llc, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro Pharm, Teva Pharms, Watson Labs, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Taro, Tris Pharma Inc, Aci Healthcare Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in forty-six NDAs. It is available from one hundred and six 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 nine suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 075360
Tradename:GABAPENTIN
Applicant:Apotex Inc
Ingredient:gabapentin
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 075360
Suppliers and Packaging for NDA: 075360
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN gabapentin CAPSULE;ORAL 075360 ANDA Major Pharmaceuticals 0904-5631 0904-5631-61 100 BLISTER PACK in 1 CARTON (0904-5631-61) > 1 CAPSULE in 1 BLISTER PACK
GABAPENTIN gabapentin CAPSULE;ORAL 075360 ANDA Major Pharmaceuticals 0904-5632 0904-5632-61 100 BLISTER PACK in 1 CARTON (0904-5632-61) > 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Apr 6, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Apr 6, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Apr 6, 2005TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
McKesson
McKinsey
Accenture
Deloitte
Chinese Patent Office
Colorcon
AstraZeneca
Fuji

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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