Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078150

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NDA 078150 describes GABAPENTIN, which is a drug marketed by Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Hikma, Invagen Pharms, Ipca Labs Ltd, Pharmazone, Pharmobedient, Prinston Inc, Rising, Sandoz, 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, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lupin, Ranbaxy, Sciegen Pharms, Teva, Teva Pharms Usa, Zydus Pharms, and Zydus Pharms Usa Inc, and is included in sixty-nine NDAs. It is available from eighty-two suppliers. Additional details are available on the GABAPENTIN profile page.

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

Summary for 078150

Tradename:	GABAPENTIN
Applicant:	Hikma
Ingredient:	gabapentin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Sep 25, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Sep 25, 2007	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Sep 25, 2007	TE:		RLD:	No

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