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Generated: August 23, 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 Epic Pharma, Sandoz, Mylan, Sun Pharm Inds, Heritage Pharms Inc, Ani Pharms Inc, and Watson Labs, and is included in twelve NDAs. It is available from twenty-one 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-one suppliers are listed for this compound. Additional details are available on the sulindac profile page.

Summary for NDA: 071891

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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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