Last Updated: November 8, 2026

Details for New Drug Application (NDA): 205321

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NDA 205321 describes PREGABALIN, which is a drug marketed by Actavis Elizabeth, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Caplin, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms, MSN, Pharmazone, Pharmobedient, Prinston Inc, Regcon Holdings, Rising, Sciegen Pharms, Somerset Theraps Llc, Strides Pharma, Sun Pharm, Teva Pharms, Torrent, Tris Pharma Inc, Unichem, Zydus Pharms, Anda Repository, 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 is one drug master file entry for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for 205321

Tradename:	PREGABALIN
Applicant:	Aurobindo Pharma
Ingredient:	pregabalin
Patents:	0

Medical Subject Heading (MeSH) Categories for 205321

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Suppliers and Packaging for NDA: 205321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREGABALIN	pregabalin	CAPSULE;ORAL	205321	ANDA	Clinical Solutions Wholesale, LLC	58118-0758	58118-0758-8	30 CAPSULE in 1 BLISTER PACK (58118-0758-8)
PREGABALIN	pregabalin	CAPSULE;ORAL	205321	ANDA	Clinical Solutions Wholesale, LLC	58118-0759	58118-0759-8	30 CAPSULE in 1 BLISTER PACK (58118-0759-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Mar 29, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Mar 29, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Mar 29, 2023	TE:	AB	RLD:	No

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