You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 19, 2026

Details for New Drug Application (NDA): 207799

✉ Email this page to a colleague

« Back to Dashboard

NDA 207799 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, 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-two 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-five suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for 207799

Tradename:	PREGABALIN
Applicant:	Alkem Labs Ltd
Ingredient:	pregabalin
Patents:	0

Medical Subject Heading (MeSH) Categories for 207799

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

Suppliers and Packaging for NDA: 207799

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREGABALIN	pregabalin	CAPSULE;ORAL	207799	ANDA	Clinical Solutions Wholesale, LLC	58118-1463	58118-1463-8	30 CAPSULE in 1 BLISTER PACK (58118-1463-8)
PREGABALIN	pregabalin	CAPSULE;ORAL	207799	ANDA	Clinical Solutions Wholesale, LLC	58118-1464	58118-1464-8	30 CAPSULE in 1 BLISTER PACK (58118-1464-8)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jul 19, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jul 19, 2019	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.