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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 211330

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NDA 211330 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 211330

Tradename:	GABAPENTIN
Applicant:	Pai Holdings Pharm
Ingredient:	gabapentin
Patents:	0

Pharmacology for NDA: 211330

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 211330

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GABAPENTIN	gabapentin	SOLUTION;ORAL	211330	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1067	0121-1067-16	470 mL in 1 BOTTLE, PLASTIC (0121-1067-16)
GABAPENTIN	gabapentin	SOLUTION;ORAL	211330	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-2134	0121-2134-40	4 TRAY in 1 CASE (0121-2134-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 6 mL in 1 CUP, UNIT-DOSE (0121-2134-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	250MG/5ML
Approval Date:	Dec 3, 2019	TE:	AA	RLD:	No

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