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Last Updated: September 22, 2020

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Details for New Drug Application (NDA): 078329

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Summary for 078329
Tradename:IBUPROFEN
Applicant:Strides Pharma
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078329
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 078329
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen TABLET;ORAL 078329 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8309 0615-8309-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8309-39)
IBUPROFEN ibuprofen TABLET;ORAL 078329 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8310 0615-8310-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8310-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Feb 5, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 5, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Feb 5, 2009TE:ABRLD:No

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