Is there a generic for Cefamandole nafate?

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

What is the reference-listed drug for Cefamandole nafate?

MANDOL (NDA 050504, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cefamandole nafate are approved?

Cefamandole nafate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Cefamandole nafate

Cefamandole nafate 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:MANDOL · NDA 050504

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MANDOL×4	LILLY	NDA 050504	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
MANDOL×2	LILLY	ANDA 062560	—	Sep 10, 1985

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.

Cefamandole nafate — frequently asked questions

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

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