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Last Updated: July 22, 2024

Details for New Drug Application (NDA): 008316

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NDA 008316 describes PRIMAQUINE, which is a drug marketed by Sanofi Aventis Us, Alvogen, Bayshore Pharms Llc, and Novast Labs, and is included in four NDAs. It is available from one supplier. Additional details are available on the PRIMAQUINE profile page.

The generic ingredient in PRIMAQUINE is primaquine phosphate. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the primaquine phosphate profile page.
Summary for 008316
Applicant:Sanofi Aventis Us
Ingredient:primaquine phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 008316
Medical Subject Heading (MeSH) Categories for 008316
Suppliers and Packaging for NDA: 008316
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMAQUINE primaquine phosphate TABLET;ORAL 008316 NDA Sanofi-Aventis U.S. LLC 0024-1596 0024-1596-01 100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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