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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Queensland Health
Boehringer Ingelheim

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071891

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NDA 071891 describes SULINDAC, which is a drug marketed by Ani Pharms Inc, Epic Pharma, Epic Pharma Llc, Mylan, Sandoz, Sun Pharm Industries, and Watson Labs, and is included in twelve NDAs. It is available from twenty-two 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. Twenty-two suppliers are listed for this compound. Additional details are available on the sulindac profile page.

Summary for 071891

Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 071891

Medical Subject Heading (MeSH) Categories for 071891

Suppliers and Packaging for NDA: 071891

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULINDAC sulindac TABLET;ORAL 071891 ANDA Actavis Pharma, Inc. 0591-5661 0591-5661-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5661-01)
SULINDAC sulindac TABLET;ORAL 071891 ANDA Actavis Pharma, Inc. 0591-5661 0591-5661-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-5661-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 3, 1990TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Queensland Health

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