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Generated: September 18, 2018

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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 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. Fourteen suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
Summary for 007073
Tradename:AZULFIDINE
Applicant:Pharmacia And Upjohn
Ingredient:sulfasalazine
Patents:0
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)

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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