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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215249

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NDA 215249 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, Hetero Labs Ltd Iii, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Pharmobedient, Prinston Inc, Regcon Holdings, Rising, Sciegen Pharms Inc, Somerset Theraps Llc, Strides Pharma, Sun Pharm, Teva Pharms, Torrent, Yiling, Zydus Pharms, Anda Repository, Aiping Pharm Inc, Alvogen, Epic Pharma Llc, and Rubicon Research, and is included in fifty NDAs. It is available from fifty-one 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-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for 215249

Tradename:	PREGABALIN
Applicant:	Rubicon Research
Ingredient:	pregabalin
Patents:	0

Medical Subject Heading (MeSH) Categories for 215249

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Suppliers and Packaging for NDA: 215249

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREGABALIN	pregabalin	TABLET, EXTENDED RELEASE;ORAL	215249	ANDA	Advagen Pharma Ltd.	72888-049	72888-049-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-049-30)
PREGABALIN	pregabalin	TABLET, EXTENDED RELEASE;ORAL	215249	ANDA	Advagen Pharma Ltd.	72888-050	72888-050-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-050-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	82.5MG
Approval Date:	Mar 22, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	165MG
Approval Date:	Mar 22, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	330MG
Approval Date:	Mar 22, 2022	TE:	AB	RLD:	No

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