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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 215577

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NDA 215577 describes PREGABALIN, which is a drug marketed by Acme Labs, 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, Hetero Labs Ltd Iii, Invagen Pharms, Lupin Ltd, MSN, Norvium Bioscience, Prinston Inc, Rising, Rk Pharma, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Anda Repository, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-five NDAs. It is available from fifty-three 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-six suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for 215577

Tradename:	PREGABALIN
Applicant:	Zydus Pharms
Ingredient:	pregabalin
Patents:	0

Medical Subject Heading (MeSH) Categories for 215577

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	82.5MG
Approval Date:	Aug 26, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	165MG
Approval Date:	Aug 26, 2022	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	330MG
Approval Date:	Aug 26, 2022	TE:		RLD:	No

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