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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 210602


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Summary for 210602
Tradename:IBUPROFEN
Applicant:Annora Pharma
Ingredient:ibuprofen
Patents:0
Pharmacology for NDA: 210602
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 210602
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen SUSPENSION;ORAL 210602 ANDA PAI Holdings, LLC dba PAI Pharma 0121-1022 0121-1022-00 10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE
IBUPROFEN ibuprofen SUSPENSION;ORAL 210602 ANDA PAI Holdings, LLC dba PAI Pharma 0121-1022 0121-1022-05 10 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Nov 23, 2018TE:RLD:No

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