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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 208113

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NDA 208113 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 208113

Tradename:	PREGABALIN
Applicant:	Regcon Holdings
Ingredient:	pregabalin
Patents:	0

Medical Subject Heading (MeSH) Categories for 208113

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Suppliers and Packaging for NDA: 208113

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREGABALIN	pregabalin	CAPSULE;ORAL	208113	ANDA	Indoco Remedies Limited	14445-123	14445-123-00	1000 CAPSULE in 1 BOTTLE (14445-123-00)
PREGABALIN	pregabalin	CAPSULE;ORAL	208113	ANDA	Indoco Remedies Limited	14445-123	14445-123-10	100 CAPSULE in 1 BLISTER PACK (14445-123-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	May 17, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	May 17, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	May 17, 2024	TE:	AB	RLD:	No

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