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Last Updated: June 13, 2024

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 Pfizer and is included in two NDAs. It is available from five 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. Ten suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
Summary for 007073
Formulation / Manufacturing:see details
Pharmacology for NDA: 007073
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 Pfizer Laboratories Div Pfizer Inc 0013-0101 0013-0101-01 100 TABLET in 1 BOTTLE (0013-0101-01)
AZULFIDINE EN-TABS sulfasalazine TABLET, DELAYED RELEASE;ORAL 007073 NDA Pfizer Laboratories Div Pfizer Inc 0013-0101 0013-0101-10 1 BOTTLE in 1 CARTON (0013-0101-10) / 100 TABLET in 1 BOTTLE

Profile for product number 001

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

Profile for product number 002

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

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