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Details for New Drug Application (NDA): 087197

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NDA 087197 describes SULFASALAZINE, which is a drug marketed by Watson Labs, Vintage Pharms, Superpharm, Sandoz, Sun Pharm Inds, and Heritage Pharms Inc, 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. Fifteen suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.

Summary for NDA: 087197

Tradename:
SULFASALAZINE
Applicant:
Watson Labs
Ingredient:
sulfasalazine
Patents:0
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 68788-9021-1 120 TABLET in 1 BOTTLE, DISPENSING (68788-9021-1)
SULFASALAZINE
sulfasalazine
TABLET;ORAL 087197 ANDA Preferred Pharmaceuticals, Inc 68788-9021 68788-9021-3 30 TABLET in 1 BOTTLE, DISPENSING (68788-9021-3)

Summary 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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