Is there a generic for Mezlocillin sodium monohydrate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Mezlocillin sodium monohydrate, referencing the brand MEZLIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mezlocillin sodium monohydrate?

MEZLIN (NDA 050549, BAYER PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mezlocillin sodium monohydrate are approved?

Mezlocillin sodium monohydrate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Mezlocillin sodium monohydrate

Mezlocillin sodium monohydrate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MEZLIN · NDA 050549

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MEZLIN×5	BAYER PHARMS	NDA 050549	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
MEZLIN×2	BAYER PHARMS	ANDA 062697	—	Jan 22, 1987
MEZLIN×5	BAYER PHARMS	ANDA 062372	—	Jan 13, 1983
MEZLIN×4	BAYER PHARMS	ANDA 062333	—	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.

Mezlocillin sodium monohydrate — frequently asked questions

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

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