Is there a generic for Hydroxocobalamin?

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

What is the reference-listed drug for Hydroxocobalamin?

CYANOKIT (NDA 022041, BTG INTL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydroxocobalamin are approved?

Hydroxocobalamin is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Hydroxocobalamin

Hydroxocobalamin 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:CYANOKIT · NDA 022041

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CYANOKITRLD×2	BTG INTL	NDA 022041	—	Apr 08, 2011

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
ALPHAREDISOL	MERCK	ANDA 080778	—	Approved Prior to Jan 1, 1982
HYDROXOCOBALAMIN	ABRAXIS PHARM	ANDA 084921	—	Approved Prior to Jan 1, 1982
HYDROXOCOBALAMIN	ACTAVIS	ANDA 085998	—	Approved Prior to Jan 1, 1982
HYDROXOCOBALAMIN	WATSON LABS	ANDA 085528	—	Approved Prior to Jan 1, 1982
HYDROXOMIN	BEL MAR	ANDA 084629	—	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.

Hydroxocobalamin — frequently asked questions

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

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