Is there a generic for Clindamycin phosphate; tretinoin?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Clindamycin phosphate; tretinoin, referencing the brand VELTIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clindamycin phosphate; tretinoin?

VELTIN (NDA 050803, ALMIRALL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Clindamycin phosphate; tretinoin are approved?

Clindamycin phosphate; tretinoin is approved in the following dosage form: gel.

FDA Orange Book · active-ingredient family

Clindamycin phosphate; tretinoin

Clindamycin phosphate; tretinoin is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VELTIN · NDA 050803

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel

Product	Applicant	Application	TE	Approved
VELTINRLD	ALMIRALL	NDA 050803	AB2	Jul 16, 2010
ZIANARLD	BAUSCH	NDA 050802	AB1	Nov 07, 2006

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
CLINDAMYCIN PHOSPHATE AND TRETINOIN	ENCUBE	ANDA 216943	AB2	Sep 01, 2023
CLINDAMYCIN PHOSPHATE AND TRETINOIN	SOLARIS PHARMA CORP	ANDA 212845	AB2	Feb 10, 2022
CLINDAMYCIN PHOSPHATE AND TRETINOIN	ACTAVIS MID ATLANTIC	ANDA 202564	AB1	Jun 12, 2015

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.

Clindamycin phosphate; tretinoin — frequently asked questions

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

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