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Serving leading biopharmaceutical companies globally:

Teva
Federal Trade Commission
Citi
Farmers Insurance
Healthtrust
Accenture
Cipla
Deloitte
Queensland Health
US Department of Justice

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077806

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NDA 077806 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 077806
Tradename:BALSALAZIDE DISODIUM
Applicant:West-ward Pharms Int
Ingredient:balsalazide disodium
Patents:0
Therapeutic Class:Inflammatory Bowel Disease Agents
Pharmacology for NDA: 077806
Ingredient-typeAminosalicylic Acids
Suppliers and Packaging for NDA: 077806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806 ANDA West-Ward Pharmaceuticals Corp. 0054-0079 N 0054-0079-28
BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806 ANDA Physicians Total Care, Inc. 54868-6137 E 54868-6137-0

Profile for product number 001

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

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Chubb
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McKesson
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US Army
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