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Serving leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
US Department of Justice

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 007073

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NDA 007073 describes AZULFIDINE, which is a drug marketed by Pharmacia And Upjohn and is included in three NDAs. It is available from six suppliers. Additional details are available on the AZULFIDINE profile page.

The generic ingredient in AZULFIDINE 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 007073

Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 007073

Ingredient-typeAminosalicylic Acids

Suppliers and Packaging for NDA: 007073

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZULFIDINE EN-TABS sulfasalazine TABLET, DELAYED RELEASE;ORAL 007073 NDA Pharmacia and Upjohn Company LLC 0013-0101 0013-0101-01 100 TABLET in 1 BOTTLE (0013-0101-01)
AZULFIDINE EN-TABS sulfasalazine TABLET, DELAYED RELEASE;ORAL 007073 NDA Pharmacia and Upjohn Company LLC 0013-0101 0013-0101-20 300 TABLET in 1 BOTTLE (0013-0101-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Apr 6, 1983TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office

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