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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 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 NDA: 007073

Pharmacia And Upjohn
Therapeutic Class:Inflammatory Bowel Disease Agents

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
TABLET, DELAYED RELEASE;ORAL 007073 NDA Pharmacia and Upjohn Company 0013-0101 0013-0101-01 100 TABLET in 1 BOTTLE (0013-0101-01)
TABLET, DELAYED RELEASE;ORAL 007073 NDA Pharmacia and Upjohn Company 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.