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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073262

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NDA 073262 describes SULINDAC, which is a drug marketed by Ani Pharms Inc, Epic Pharma, Epic Pharma Llc, Fosun Pharma, Mylan, Sun Pharm Industries, 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 073262
Applicant:Epic Pharma Llc
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 073262
Medical Subject Heading (MeSH) Categories for 073262
Suppliers and Packaging for NDA: 073262
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULINDAC sulindac TABLET;ORAL 073262 ANDA Heritage Pharmaceuticals Inc. 23155-005 E 23155-005-05
SULINDAC sulindac TABLET;ORAL 073262 ANDA Heritage Pharmaceuticals Inc. 23155-005 E 23155-005-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 6, 1991TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 6, 1991TE:ABRLD:No

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