Is there a generic for Mivacurium chloride?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Mivacurium chloride, referencing the brand MIVACRON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mivacurium chloride?

MIVACRON (NDA 020098, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mivacurium chloride are approved?

Mivacurium chloride is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Mivacurium chloride

Mivacurium chloride is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MIVACRON · NDA 020098

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
MIVACRONRLD×5	ABBVIE	NDA 020098	—	Jan 22, 1992

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
MIVACURIUM CHLORIDE×2	WOODWARD	ANDA 209708	—	Oct 12, 2021
MIVACURIUM CHLORIDE	RISING	ANDA 078562	—	Apr 30, 2009

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.

Mivacurium chloride — 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