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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
US Army
Johnson and Johnson

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077883

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NDA 077883 describes BALSALAZIDE DISODIUM, which is a drug marketed by Apotex Inc, Mylan, West-ward Pharms Int, and Par Pharm Inc, and is included in four NDAs. It is available from eight suppliers. Additional details are available on the BALSALAZIDE DISODIUM profile page.

The generic ingredient in BALSALAZIDE DISODIUM is balsalazide disodium. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
Summary for 077883
Applicant:Apotex Inc
Ingredient:balsalazide disodium
Therapeutic Class:Inflammatory Bowel Disease Agents
Pharmacology for NDA: 077883
Ingredient-typeAminosalicylic Acids
Suppliers and Packaging for NDA: 077883
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883 ANDA AvKARE, Inc. 42291-157 N 42291-157-28
BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883 ANDA AvPAK 50268-102 N 50268-102-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength750MG
Approval Date:Dec 28, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
Boehringer Ingelheim
Chinese Patent Office

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