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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 077661

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NDA 077661 describes GABAPENTIN, which is a drug marketed by Actavis Elizabeth, Alkem, Amneal Pharms Ny, Anda Repository, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Hikma, Invagen Pharms, Ipca Labs Ltd, Laurus, Marksans Pharma, Pharmobedient, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Acella Pharms Llc, Ajenat Pharms, Amneal Pharms, Annora Pharma, Mission Pharmacal, Pai Holdings Pharm, Rubicon Research, Abon Pharms Llc, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Hikma Pharms, Humanwell, Ivax Sub Teva Pharms, Lupin Ltd, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms, and Zydus Pharms Usa Inc, and is included in sixty-eight NDAs. It is available from seventy-nine suppliers. Additional details are available on the GABAPENTIN profile page.

The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-three suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for 077661

Tradename:	GABAPENTIN
Applicant:	Rubicon Research
Ingredient:	gabapentin
Patents:	0

Pharmacology for NDA: 077661

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 077661

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GABAPENTIN	gabapentin	TABLET;ORAL	077661	ANDA	Advagen Pharma Ltd	72888-131	72888-131-00	1000 TABLET in 1 BOTTLE (72888-131-00)
GABAPENTIN	gabapentin	TABLET;ORAL	077661	ANDA	Advagen Pharma Ltd	72888-131	72888-131-01	100 TABLET in 1 BOTTLE (72888-131-01)

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Sep 13, 2006	TE:	AB1	RLD:	No

Profile for product number 005

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Sep 13, 2006	TE:	AB1	RLD:	No

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