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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075339

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NDA 075339 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 075339
Applicant:Vintage Pharms
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075339
Ingredient-typeAminosalicylic Acids
Suppliers and Packaging for NDA: 075339
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFASALAZINE sulfasalazine TABLET, DELAYED RELEASE;ORAL 075339 ANDA Qualitest Pharmaceuticals 0603-5803 N 0603-5803-32
SULFASALAZINE sulfasalazine TABLET, DELAYED RELEASE;ORAL 075339 ANDA Qualitest Pharmaceuticals 0603-5803 N 0603-5803-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Jan 11, 2002TE:ABRLD:No

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