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Daiichi Sankyo
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Cantor Fitzgerald
Chinese Patent Office
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Fish and Richardson

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087197

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NDA 087197 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 nine 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. Fourteen suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
Summary for 087197
Applicant:Watson Labs
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 087197
Ingredient-typeAminosalicylic Acids
Suppliers and Packaging for NDA: 087197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFASALAZINE sulfasalazine TABLET;ORAL 087197 ANDA Preferred Pharmaceuticals, Inc 68788-9021 N 68788-9021-1
SULFASALAZINE sulfasalazine TABLET;ORAL 087197 ANDA Preferred Pharmaceuticals, Inc 68788-9021 N 68788-9021-3

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Argus Health
Express Scripts
Farmers Insurance

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