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Last Updated: May 18, 2024

Details for New Drug Application (NDA): 021024

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NDA 021024 describes PRIFTIN, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from three suppliers. Additional details are available on the PRIFTIN profile page.

The generic ingredient in PRIFTIN is rifapentine. Three suppliers are listed for this compound. Additional details are available on the rifapentine profile page.
Summary for 021024
Applicant:Sanofi Aventis Us
Formulation / Manufacturing:see details
Pharmacology for NDA: 021024
Suppliers and Packaging for NDA: 021024
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIFTIN rifapentine TABLET;ORAL 021024 NDA sanofi-aventis U.S. LLC 0088-2102 0088-2102-24 3 BLISTER PACK in 1 CARTON (0088-2102-24) / 8 TABLET, FILM COATED in 1 BLISTER PACK (0088-2102-01)
PRIFTIN rifapentine TABLET;ORAL 021024 NDA A-S Medication Solutions 50090-5063 50090-5063-0 3 BLISTER PACK in 1 CARTON (50090-5063-0) / 8 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jun 22, 1998TE:RLD:Yes

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