You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 16, 2025

Details for New Drug Application (NDA): 071795

✉ Email this page to a colleague

« Back to Dashboard

NDA 071795 describes SULINDAC, which is a drug marketed by Ani Pharms, Chartwell Rx, Epic Pharma, Epic Pharma Llc, Rising, Sun Pharm Industries, and Watson Labs, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the SULINDAC profile page.

The generic ingredient in SULINDAC is sulindac. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sulindac profile page.

Summary for 071795

Tradename:	SULINDAC
Applicant:	Watson Labs
Ingredient:	sulindac
Patents:	0

Pharmacology for NDA: 071795

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 071795

Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 071795

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULINDAC	sulindac	TABLET;ORAL	071795	ANDA	Actavis Pharma, Inc.	0591-5660	0591-5660-01	100 TABLET in 1 BOTTLE, PLASTIC (0591-5660-01)
SULINDAC	sulindac	TABLET;ORAL	071795	ANDA	Actavis Pharma, Inc.	0591-5660	0591-5660-05	500 TABLET in 1 BOTTLE, PLASTIC (0591-5660-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Apr 3, 1990	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.