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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 202300


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Summary for 202300
Tradename:IBUPROFEN
Applicant:Amneal Pharms
Ingredient:ibuprofen
Patents:0
Pharmacology for NDA: 202300
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 202300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen CAPSULE;ORAL 202300 ANDA The Kroger Co. 30142-728 30142-728-80 1 BOTTLE, PLASTIC in 1 BOX (30142-728-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
IBUPROFEN ibuprofen CAPSULE;ORAL 202300 ANDA H E B 37808-221 37808-221-20 1 BOTTLE, PLASTIC in 1 BOX (37808-221-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrengthEQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Dec 23, 2011TE:RLD:No

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