Is there a generic for Metaraminol bitartrate?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Metaraminol bitartrate, referencing the brand ARAMINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Metaraminol bitartrate?

ARAMINE (NDA 009509, MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Metaraminol bitartrate are approved?

Metaraminol bitartrate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Metaraminol bitartrate

Metaraminol bitartrate is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARAMINE · NDA 009509

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ARAMINERLD	MERCK	NDA 009509	—	Dec 22, 1987

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
METARAMINOL BITARTRATE	AZURITY	ANDA 211304	—	Aug 24, 2021
METARAMINOL BITARTRATE	ABRAXIS PHARM	ANDA 080431	—	Approved Prior to Jan 1, 1982
METARAMINOL BITARTRATE	ELKINS SINN	ANDA 083363	—	Approved Prior to Jan 1, 1982
METARAMINOL BITARTRATE	FRESENIUS KABI USA	ANDA 080722	—	Approved Prior to Jan 1, 1982
METARAMINOL BITARTRATE×2	GD SEARLE LLC	ANDA 086418	—	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.

Metaraminol bitartrate — frequently asked questions

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

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