Last Updated: November 8, 2026

Details for New Drug Application (NDA): 072711

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NDA 072711 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 seven suppliers. Additional details are available on the SULINDAC profile page.

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

Summary for 072711

Tradename:	SULINDAC
Applicant:	Epic Pharma
Ingredient:	sulindac
Patents:	0

Pharmacology for NDA: 072711

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 072711

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

Suppliers and Packaging for NDA: 072711

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULINDAC	sulindac	TABLET;ORAL	072711	ANDA	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-771	24658-771-01	100 TABLET in 1 BOTTLE (24658-771-01)
SULINDAC	sulindac	TABLET;ORAL	072711	ANDA	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-771	24658-771-05	500 TABLET in 1 BOTTLE (24658-771-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Mar 25, 1991	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Mar 25, 1991	TE:	AB	RLD:	No

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