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Last Updated: March 28, 2024

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 eleven NDAs. It is available from nine 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. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 072051
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 072051
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:RXDosage:TABLET;ORALStrength200MG
Approval Date:Apr 17, 1991TE:ABRLD:No

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