Is there a generic for Alfentanil hydrochloride?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Alfentanil hydrochloride, referencing the brand ALFENTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Alfentanil hydrochloride?

ALFENTA (NDA 019353, RISING) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Alfentanil hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Alfentanil hydrochloride

Alfentanil hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALFENTA · NDA 019353

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ALFENTARLD	RISING	NDA 019353	—	Dec 29, 1986

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ALFENTANIL	HOSPIRA	ANDA 075221	—	Oct 28, 1999

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.

Alfentanil hydrochloride — frequently asked questions

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

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