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Generated: January 21, 2019

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Details for New Drug Application (NDA): 071265

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NDA 071265 describes PROFEN, which is a drug marketed by Contract Pharmacal and Alcon and is included in two NDAs. It is available from one supplier. Additional details are available on the PROFEN profile page.

The generic ingredient in PROFEN is suprofen. There are four drug master file entries for this compound. Additional details are available on the suprofen profile page.
Summary for 071265
Applicant:Contract Pharmacal
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 071265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROFEN ibuprofen TABLET;ORAL 071265 ANDA Contract Pharmacal Corp. 10267-3846 10267-3846-2 250 TABLET in 1 BOTTLE (10267-3846-2)
PROFEN ibuprofen TABLET;ORAL 071265 ANDA Contract Pharmacal Corp. 10267-3852 10267-3852-2 250 TABLET in 1 BOTTLE (10267-3852-2)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:Oct 15, 1986TE:RLD:No

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