Is there a generic for Droperidol; fentanyl citrate?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Droperidol; fentanyl citrate, referencing the brand INNOVAR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Droperidol; fentanyl citrate?

INNOVAR (NDA 016049, EPIC PHARMA LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Droperidol; fentanyl citrate are approved?

Droperidol; fentanyl citrate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Droperidol; fentanyl citrate

Droperidol; fentanyl citrate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INNOVAR · NDA 016049

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
INNOVAR	EPIC PHARMA LLC	NDA 016049	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
FENTANYL CITRATE AND DROPERIDOL	ASTRAZENECA	ANDA 072026	—	Apr 13, 1989
FENTANYL CITRATE AND DROPERIDOL	ASTRAZENECA	ANDA 072027	—	Apr 13, 1989
FENTANYL CITRATE AND DROPERIDOL	ASTRAZENECA	ANDA 072028	—	Apr 13, 1989
FENTANYL CITRATE AND DROPERIDOL	HOSPIRA	ANDA 071982	—	May 04, 1988

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.

Droperidol; fentanyl citrate — frequently asked questions

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

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