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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 090858

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NDA 090858 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, 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, 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 eighty 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-four suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for 090858

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

Pharmacology for NDA: 090858

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 090858

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GABAPENTIN	gabapentin	CAPSULE;ORAL	090858	ANDA	Major Pharmaceuticals	0904-6665	0904-6665-61	100 BLISTER PACK in 1 CARTON (0904-6665-61) / 1 CAPSULE in 1 BLISTER PACK
GABAPENTIN	gabapentin	CAPSULE;ORAL	090858	ANDA	Major Pharmaceuticals	0904-6666	0904-6666-61	100 BLISTER PACK in 1 CARTON (0904-6666-61) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 17, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Dec 17, 2010	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Dec 17, 2010	TE:	AB	RLD:	No

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