Is there a generic for Pyrvinium pamoate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Pyrvinium pamoate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Pyrvinium pamoate?

POVAN (NDA 011964, PARKE DAVIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pyrvinium pamoate are approved?

Pyrvinium pamoate is approved in the following dosage forms: suspension, tablet.

FDA Orange Book · active-ingredient family

Pyrvinium pamoate

Pyrvinium pamoate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:POVAN · NDA 011964

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension, tablet

Product	Applicant	Application	TE	Approved
POVAN	PARKE DAVIS	NDA 011964	—	Approved Prior to Jan 1, 1982
POVAN	PARKE DAVIS	NDA 012485	—	Approved Prior to Jan 1, 1982

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.

Pyrvinium pamoate — frequently asked questions

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

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