Last Updated: May 3, 2026

Details for New Drug Application (NDA): 218529

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NDA 218529 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, Yiling, Zydus Pharms, Patrin, Aiping Pharm Inc, Alvogen, Epic Pharma Llc, and Rubicon Research, and is included in fifty-one 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 218529

Tradename:	PREGABALIN
Applicant:	Fourrts Labs
Ingredient:	pregabalin
Patents:	0

Medical Subject Heading (MeSH) Categories for 218529

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Suppliers and Packaging for NDA: 218529

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREGABALIN	pregabalin	CAPSULE;ORAL	218529	ANDA	FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED	82968-006	82968-006-01	90 CAPSULE in 1 BOTTLE (82968-006-01)
PREGABALIN	pregabalin	CAPSULE;ORAL	218529	ANDA	FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED	82968-007	82968-007-01	90 CAPSULE in 1 BOTTLE (82968-007-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Feb 24, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Feb 24, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Feb 24, 2026	TE:	AB	RLD:	No

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