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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 077349


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Summary for 077349
Tradename:IBUPROFEN
Applicant:Perrigo R And D
Ingredient:ibuprofen
Patents:0
Pharmacology for NDA: 077349
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 077349
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen TABLET;ORAL 077349 ANDA L. Perrigo Company 0113-0074 0113-0074-71 1 BOTTLE in 1 CARTON (0113-0074-71) / 50 TABLET, FILM COATED in 1 BOTTLE
IBUPROFEN ibuprofen TABLET;ORAL 077349 ANDA L. Perrigo Company 0113-0074 0113-0074-78 1 BOTTLE in 1 CARTON (0113-0074-78) / 100 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Jun 21, 2005TE:RLD:No

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