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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Argus Health

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206336

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NDA 206336 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. Eleven suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
Summary for 206336
Applicant:Par Pharm Inc
Ingredient:balsalazide disodium
Therapeutic Class:Inflammatory Bowel Disease Agents
Pharmacology for NDA: 206336
Ingredient-typeAminosalicylic Acids
Suppliers and Packaging for NDA: 206336
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BALSALAZIDE DISODIUM balsalazide disodium TABLET;ORAL 206336 ANDA Par Pharmaceutical Inc. 49884-367 N 49884-367-13
BALSALAZIDE DISODIUM balsalazide disodium TABLET;ORAL 206336 ANDA Par Pharmaceutical Inc. 49884-367 N 49884-367-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.1GM
Approval Date:Sep 8, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
US Army

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