Is there a generic for Erythromycin gluceptate?

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

What is the reference-listed drug for Erythromycin gluceptate?

ILOTYCIN GLUCEPTATE (NDA 050370, DISTA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Erythromycin gluceptate are approved?

Erythromycin gluceptate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Erythromycin gluceptate

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

Reference-listed drug:ILOTYCIN GLUCEPTATE · NDA 050370

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ILOTYCIN GLUCEPTATE×3	DISTA	NDA 050370	—	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.

Erythromycin gluceptate — frequently asked questions

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

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