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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 203934

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NDA 203934 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, Laurus, Marksans Pharma, Pharmobedient, Rising, Sandoz, Sciegen Pharms Inc, Senores Pharms, 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, Anda Repository, 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 203934

Tradename:	GABAPENTIN
Applicant:	Zydus Pharms
Ingredient:	gabapentin
Patents:	0

Pharmacology for NDA: 203934

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 203934

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GABAPENTIN	gabapentin	TABLET;ORAL	203934	ANDA	Zydus Pharmaceuticals USA Inc.	68382-355	68382-355-01	100 TABLET in 1 BOTTLE (68382-355-01)
GABAPENTIN	gabapentin	TABLET;ORAL	203934	ANDA	Zydus Pharmaceuticals USA Inc.	68382-355	68382-355-14	60 TABLET in 1 BOTTLE (68382-355-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jan 24, 2024	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Jan 24, 2024	TE:	AB2	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	450MG
Approval Date:	Aug 25, 2025	TE:	AB	RLD:	No

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