Is there a generic for Primaquine phosphate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Primaquine phosphate, referencing the brand PRIMAQUINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Primaquine phosphate?

PRIMAQUINE (NDA 008316, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Primaquine phosphate are approved?

Primaquine phosphate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Primaquine phosphate

Primaquine phosphate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PRIMAQUINE · NDA 008316

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
PRIMAQUINERLD	SANOFI AVENTIS US	NDA 008316	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
PRIMAQUINE PHOSPHATE	INGENUS PHARMS LLC	ANDA 206043	AB	Jun 23, 2016
PRIMAQUINE PHOSPHATE	UNICHEM	ANDA 204476	AB	Feb 25, 2014
PRIMAQUINE PHOSPHATE	ALVOGEN	ANDA 203924	—	Feb 03, 2014

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Primaquine phosphate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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