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Last Updated: February 28, 2021

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Details for New Drug Application (NDA): 210755

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Summary for 210755
Tradename:IBUPROFEN
Applicant:Guardian Drug
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 210755
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen SUSPENSION/DROPS;ORAL 210755 ANDA Wal-Mart Stores, Inc. 49035-635 49035-635-09 1 BOTTLE in 1 CARTON (49035-635-09) > 30 mL in 1 BOTTLE
IBUPROFEN ibuprofen SUSPENSION/DROPS;ORAL 210755 ANDA Guardian Drug Company 53041-637 53041-637-09 1 BOTTLE in 1 CARTON (53041-637-09) > 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION/DROPS;ORALStrength40MG/ML
Approval Date:Sep 26, 2018TE:RLD:No

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