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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090158

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NDA 090158 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 one 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 four suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 090158

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

Pharmacology for NDA: 090158

Suppliers and Packaging for NDA: 090158

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABAPENTIN
gabapentin
CAPSULE;ORAL 090158 ANDA Mylan Pharmaceuticals Inc. 0378-5426 0378-5426-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5426-01)
GABAPENTIN
gabapentin
CAPSULE;ORAL 090158 ANDA Mylan Pharmaceuticals Inc. 0378-5426 0378-5426-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-5426-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 14, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Feb 14, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Feb 14, 2011TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Army
Deloitte
Healthtrust
Daiichi Sankyo
Fuji
Chinese Patent Office
Cantor Fitzgerald
Queensland Health
Citi
Medtronic

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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