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Last Updated: December 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

Tradename:	PRIMAQUINE
Applicant:	Sanofi Aventis Us
Ingredient:	primaquine phosphate
Patents:	0

Pharmacology for NDA: 008316

Medical Subject Heading (MeSH) Categories for 008316

Antimalarials

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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 15MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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