Is there a generic for Cefotiam hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Cefotiam hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Cefotiam hydrochloride?

CERADON (NDA 050601, TAKEDA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cefotiam hydrochloride are approved?

Cefotiam hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Cefotiam hydrochloride

Cefotiam hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CERADON · NDA 050601

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CERADON	TAKEDA	NDA 050601	—	Dec 30, 1988

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.

Cefotiam hydrochloride — frequently asked questions

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

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