Is there a generic for Pentolinium tartrate?

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

What is the reference-listed drug for Pentolinium tartrate?

ANSOLYSEN (NDA 009372, WYETH AYERST) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pentolinium tartrate are approved?

Pentolinium tartrate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Pentolinium tartrate

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

Reference-listed drug:ANSOLYSEN · NDA 009372

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ANSOLYSEN	WYETH AYERST	NDA 009372	—	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.

Pentolinium tartrate — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo