Is there a generic for Spectinomycin hydrochloride?

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

What is the reference-listed drug for Spectinomycin hydrochloride?

TROBICIN (NDA 050347, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Spectinomycin hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Spectinomycin hydrochloride

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

Reference-listed drug:TROBICIN · NDA 050347

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
TROBICIN×2	PFIZER	NDA 050347	—	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.

Spectinomycin hydrochloride — frequently asked questions

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

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