Is there a generic for Benzoyl peroxide; erythromycin?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Benzoyl peroxide; erythromycin, referencing the brand AKTIPAK. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Benzoyl peroxide; erythromycin?

AKTIPAK (NDA 050769, BIOFRONTERA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Benzoyl peroxide; erythromycin are approved?

Benzoyl peroxide; erythromycin is approved in the following dosage form: gel.

FDA Orange Book · active-ingredient family

Benzoyl peroxide; erythromycin

Benzoyl peroxide; erythromycin is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AKTIPAK · NDA 050769

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel

Product	Applicant	Application	TE	Approved
AKTIPAKRLD	BIOFRONTERA	NDA 050769	—	Nov 27, 2000
BENZAMYCINRLD	VALEANT INTL	NDA 050557	AB	Oct 26, 1984

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
ERYTHROMYCIN AND BENZOYL PEROXIDE	RISING	ANDA 065385	AB	Sep 18, 2015
ERYTHROMYCIN AND BENZOYL PEROXIDE	ENCUBE	ANDA 065112	—	Mar 29, 2004

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.

Benzoyl peroxide; erythromycin — frequently asked questions

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

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