Is there a generic for Troleandomycin?

The FDA Orange Book does not currently list an approved generic (ANDA) for Troleandomycin. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Troleandomycin?

TAO (NDA 050336, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Troleandomycin are approved?

Troleandomycin is approved in the following dosage forms: capsule, suspension.

FDA Orange Book · active-ingredient family

Troleandomycin

Troleandomycin is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TAO · NDA 050336

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, suspension

Product	Applicant	Application	TE	Approved
TAO	PFIZER	NDA 050336	—	Approved Prior to Jan 1, 1982
TAO	PFIZER	NDA 050332	—	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.

Troleandomycin — frequently asked questions

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

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