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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077883

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NDA 077883 describes BALSALAZIDE DISODIUM, which is a drug marketed by Apotex Inc, Hikma Pharms, Mylan, and Par Pharm Inc, and is included in four NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
Summary for 077883
Applicant:Apotex Inc
Ingredient:balsalazide disodium
Pharmacology for NDA: 077883
Suppliers and Packaging for NDA: 077883
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883 ANDA AvKARE, Inc. 42291-157 42291-157-28 280 CAPSULE in 1 BOTTLE (42291-157-28)
BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883 ANDA AvPAK 50268-102 50268-102-13 30 BLISTER PACK in 1 BOX (50268-102-13) > 1 CAPSULE in 1 BLISTER PACK (50268-102-11)

Profile for product number 001

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

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