Last Updated: November 7, 2026

Details for New Drug Application (NDA): 219319

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NDA 219319 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 219319

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

Pharmacology for NDA: 219319

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 219319

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GABAPENTIN	gabapentin	CAPSULE;ORAL	219319	ANDA	Amici Pharma, Inc.	69292-640	69292-640-01	100 CAPSULE in 1 BOTTLE (69292-640-01)
GABAPENTIN	gabapentin	CAPSULE;ORAL	219319	ANDA	Amici Pharma, Inc.	69292-640	69292-640-10	1000 CAPSULE in 1 BOTTLE (69292-640-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Aug 7, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Aug 7, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Aug 7, 2025	TE:	AB	RLD:	No

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