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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 078682


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Summary for 078682
Tradename:IBUPROFEN
Applicant:Bionpharma
Ingredient:ibuprofen
Patents:0
Pharmacology for NDA: 078682
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 078682
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen CAPSULE;ORAL 078682 ANDA WALGREEN COMPANY 0363-0103 0363-0103-26 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (0363-0103-26)
IBUPROFEN ibuprofen CAPSULE;ORAL 078682 ANDA WALGREEN COMPANY 0363-0221 0363-0221-11 1 BOTTLE in 1 CARTON (0363-0221-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrengthEQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Mar 24, 2009TE:RLD:No

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