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Details for New Drug Application (NDA): 077883

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NDA 077883 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: 077883

Apotex Inc
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
CAPSULE;ORAL 077883 ANDA AvKARE, Inc. 42291-157 42291-157-28 280 CAPSULE in 1 BOTTLE (42291-157-28)
balsalazide disodium
CAPSULE;ORAL 077883 ANDA AvPAK 50268-102 50268-102-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-102-13) > 1 CAPSULE in 1 BLISTER PACK (50268-102-11)

Summary for product number 001

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

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