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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211384

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NDA 211384 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 211384

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

Medical Subject Heading (MeSH) Categories for 211384

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Suppliers and Packaging for NDA: 211384

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREGABALIN	pregabalin	CAPSULE;ORAL	211384	ANDA	Cipla USA, Inc.	69097-954	69097-954-05	90 CAPSULE in 1 BOTTLE (69097-954-05)
PREGABALIN	pregabalin	CAPSULE;ORAL	211384	ANDA	Cipla USA, Inc.	69097-954	69097-954-12	500 CAPSULE in 1 BOTTLE (69097-954-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jul 19, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jul 19, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	75MG
Approval Date:	Jul 19, 2019	TE:	AB	RLD:	No

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