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Details for New Drug Application (NDA): 077242

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NDA 077242 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, 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, Glenmark Generics, Hi Tech Pharma, Hikma Pharms, Watson Labs, Tris Pharma Inc, and Aurobindo Pharm, and is included in forty-two NDAs. It is available from ninety-five 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. Ninety-eight suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 077242

Sun Pharm Inds Ltd
Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 077242

Suppliers and Packaging for NDA: 077242

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 077242 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-950 35356-950-30 30 CAPSULE in 1 BOTTLE (35356-950-30)
CAPSULE;ORAL 077242 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-950 35356-950-60 60 CAPSULE in 1 BOTTLE (35356-950-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 24, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Aug 24, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Aug 24, 2006TE:ABRLD:No

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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.