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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 014860

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NDA 014860 describes ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE profile page.

The generic ingredient in ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE is chloroquine phosphate; primaquine phosphate. There are twenty drug master file entries for this compound. Additional details are available on the chloroquine phosphate; primaquine phosphate profile page.

Summary for 014860

Tradename:	ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
Applicant:	Sanofi Aventis Us
Ingredient:	chloroquine phosphate; primaquine phosphate
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE;EQ 45MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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