Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 23, 2019

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 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. Seven 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
Pharmacology for NDA: 077806
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 0054-0079-28 280 CAPSULE in 1 BOTTLE (0054-0079-28)
BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806 ANDA GSMS, Incorporated 60429-952 60429-952-28 280 CAPSULE in 1 BOTTLE (60429-952-28)

Profile for product number 001

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

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