Is there a generic for Conivaptan hydrochloride?

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

What is the reference-listed drug for Conivaptan hydrochloride?

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER (NDA 021697, CUMBERLAND) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Conivaptan hydrochloride are approved?

Conivaptan hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Conivaptan hydrochloride

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

Reference-listed drug:VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER · NDA 021697

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINERRLD×2	CUMBERLAND	NDA 021697	—	Oct 08, 2008

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.

Conivaptan hydrochloride — 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