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Details for New Drug Application (NDA): 206336

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NDA 206336 describes BALSALAZIDE DISODIUM, which is a drug marketed by Roxane, Mylan, Par Pharm Inc, and Apotex Inc, and is included in four NDAs. It is available from nine 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. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the balsalazide disodium profile page.

Summary for NDA: 206336

Par Pharm Inc
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
TABLET;ORAL 206336 ANDA Par Pharmaceutical Inc. 49884-367 49884-367-05 500 TABLET in 1 BOTTLE (49884-367-05)
balsalazide disodium
TABLET;ORAL 206336 ANDA Par Pharmaceutical Inc. 49884-367 49884-367-13 180 TABLET in 1 BOTTLE (49884-367-13)

Summary for product number 001

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

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