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Last Updated: January 23, 2020

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Details for New Drug Application (NDA): 207095

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Summary for 207095
Tradename:IBUPROFEN
Applicant:Shandong Xinhua
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen TABLET;ORAL 207095 ANDA AiPing Pharmaceutical, Inc. 11788-003 11788-003-00 50864 TABLET, FILM COATED in 1 CARTON (11788-003-00)
IBUPROFEN ibuprofen TABLET;ORAL 207095 ANDA AiPing Pharmaceutical, Inc. 11788-003 11788-003-07 1 BOTTLE in 1 CARTON (11788-003-07) > 24 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:May 5, 2017TE:RLD:No

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