Last Updated: June 8, 2026

Details for New Drug Application (NDA): 210891

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NDA 210891 describes PREGABALIN, which is a drug marketed by Actavis Elizabeth, Adaptis, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Eskayef, Fourrts Labs, Hetero Labs Ltd Iii, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Pharmobedient, Prinston Inc, Regcon Holdings, Renata, Rising, Sciegen Pharms, Strides Pharma, Sun Pharm, Teva Pharms, Torrent, Unichem, Yiling, Zydus Pharms, Patrin, Aiping Pharm Inc, Alvogen, Epic Pharma Llc, and Rubicon Research, and is included in fifty-two NDAs. It is available from fifty-two suppliers. Additional details are available on the PREGABALIN profile page.

The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for 210891

Tradename:	PREGABALIN
Applicant:	Yiling
Ingredient:	pregabalin
Patents:	0

Medical Subject Heading (MeSH) Categories for 210891

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Sep 30, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Sep 30, 2019	TE:	AB	RLD:	No

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