Is there a generic for Pentosan polysulfate sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Pentosan polysulfate sodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Pentosan polysulfate sodium?

ELMIRON (NDA 020193, JANSSEN PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pentosan polysulfate sodium are approved?

Pentosan polysulfate sodium is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Pentosan polysulfate sodium

Pentosan polysulfate sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ELMIRON · NDA 020193

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
ELMIRONRLD	JANSSEN PHARMS	NDA 020193	—	Sep 26, 1996

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.

Pentosan polysulfate sodium — frequently asked questions

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

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