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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 one supplier. Additional details are available on the PRIFTIN profile page.

The generic ingredient in PRIFTIN is rifapentine. One supplier is listed for this compound. Additional details are available on the rifapentine profile page.

Summary for NDA: 021024

Tradename:
PRIFTIN
Applicant:
Sanofi Aventis Us
Ingredient:
rifapentine
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021024

Ingredient-typeRifamycins

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 0088-2100 0088-2100-03 4 POUCH in 1 CARTON (0088-2100-03) > 1 BLISTER PACK in 1 POUCH > 8 TABLET, FILM COATED in 1 BLISTER PACK
PRIFTIN
rifapentine
TABLET;ORAL 021024 NDA sanofi-aventis U.S. LLC 0088-2100 0088-2100-24 3 POUCH in 1 CARTON (0088-2100-24) > 8 BLISTER PACK in 1 POUCH > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

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


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