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Generated: May 24, 2017

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Balsalazide disodium - Generic Drug Details

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What are the generic sources for balsalazide disodium and what is the scope of balsalazide disodium freedom to operate?

Balsalazide disodium
is the generic ingredient in three branded drugs marketed by Valeant Pharms Intl, West-ward Pharms Int, Mylan, Par Pharm Inc, and Apotex Inc, and is included in six NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has fifty-seven patent family members in nineteen countries.

There are ten drug master file entries for balsalazide disodium. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: balsalazide disodium

Drug Master File Entries: see list10
Suppliers / Packagers: see list13
Bulk Api Vendors: see list96
Clinical Trials: see list53
Patent Applications: see list3,383
Therapeutic Class:Inflammatory Bowel Disease Agents
Drug Prices:see low prices
DailyMed Link:balsalazide disodium at DailyMed

Pharmacology for Ingredient: balsalazide disodium

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Tentative approvals for BALSALAZIDE DISODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe1.1GTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Intl
balsalazide disodium
CAPSULE;ORAL020610-001Jul 18, 2000ABRXYesYes7,452,872*PED► SubscribeY► Subscribe
West-ward Pharms Int
balsalazide disodium
CAPSULE;ORAL077806-001Dec 28, 2007BXRXNoNo► Subscribe► Subscribe
Apotex Inc
balsalazide disodium
CAPSULE;ORAL077883-001Dec 28, 2007ABRXNoNo► Subscribe► Subscribe
balsalazide disodium
CAPSULE;ORAL077807-001Dec 28, 2007ABRXNoNo► Subscribe► Subscribe
Par Pharm Inc
balsalazide disodium
TABLET;ORAL206336-001Sep 8, 2015ABRXNoNo► Subscribe► Subscribe
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