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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
Federal Trade Commission
Harvard Business School
Cantor Fitzgerald
Queensland Health

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085828

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NDA 085828 describes SULFASALAZINE, which is a drug marketed by Vintage Pharms, Watson Labs, Heritage Pharms Inc, Sandoz, Sun Pharm Industries, and Superpharm, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the SULFASALAZINE profile page.

The generic ingredient in SULFASALAZINE is sulfasalazine. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
Summary for 085828
Applicant:Watson Labs
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085828
Ingredient-typeAminosalicylic Acids
Suppliers and Packaging for NDA: 085828
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFASALAZINE sulfasalazine TABLET;ORAL 085828 ANDA Actavis Pharma, Inc. 0591-0796 N 0591-0796-01
SULFASALAZINE sulfasalazine TABLET;ORAL 085828 ANDA Actavis Pharma, Inc. 0591-0796 N 0591-0796-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Boehringer Ingelheim

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