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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 079174

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Summary for 079174
Tradename:IBUPROFEN
Applicant:Granules India
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 079174
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN ibuprofen TABLET;ORAL 079174 ANDA Acme United Corporation 0924-0076 0924-0076-01 50 PACKET in 1 CARTON (0924-0076-01) > 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00)
IBUPROFEN ibuprofen TABLET;ORAL 079174 ANDA Acme United Corporation 0924-0076 0924-0076-03 10 PACKET in 1 CARTON (0924-0076-03) > 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Dec 10, 2010TE:RLD:No

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