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Last Updated: January 17, 2020

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Details for New Drug Application (NDA): 202413

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Summary for 202413
Tradename:IBUPROFEN
Applicant:Shandong Xinhua
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202413
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 202413
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen TABLET;ORAL 202413 ANDA AiPing Pharmaceutical, Inc. 11788-008 11788-008-00 34000 TABLET, FILM COATED in 1 CARTON (11788-008-00)
IBUPROFEN ibuprofen TABLET;ORAL 202413 ANDA AiPing Pharmaceutical, Inc. 11788-008 11788-008-01 100 TABLET, FILM COATED in 1 BOTTLE (11788-008-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Nov 23, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Nov 23, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Nov 23, 2016TE:ABRLD:No

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