Is there a generic for Chlortetracycline hydrochloride?

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

What is the reference-listed drug for Chlortetracycline hydrochloride?

AUREOMYCIN (NDA 050404, LEDERLE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Chlortetracycline hydrochloride are approved?

Chlortetracycline hydrochloride is approved in the following dosage form: ointment.

FDA Orange Book · active-ingredient family

Chlortetracycline hydrochloride

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

Reference-listed drug:AUREOMYCIN · NDA 050404

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · ointment

Product	Applicant	Application	TE	Approved
AUREOMYCIN	LEDERLE	NDA 050404	—	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.

Chlortetracycline hydrochloride — frequently asked questions

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

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