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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 072051

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NDA 072051 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 072051

Tradename:	SULINDAC
Applicant:	Sun Pharm Industries
Ingredient:	sulindac
Patents:	0

Pharmacology for NDA: 072051

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 072051

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

Suppliers and Packaging for NDA: 072051

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULINDAC	sulindac	TABLET;ORAL	072051	ANDA	Major Pharmaceuticals	0904-7335	0904-7335-60	100 TABLET in 1 BOTTLE, PLASTIC (0904-7335-60)
SULINDAC	sulindac	TABLET;ORAL	072051	ANDA	A-S Medication Solutions	50090-2093	50090-2093-4	60 TABLET in 1 BOTTLE (50090-2093-4)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Apr 17, 1991	TE:	AB	RLD:	No

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