Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216943
Company: ENCUBE

Products on ANDA 216943

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE AND TRETINOIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216943

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216943

CLINDAMYCIN PHOSPHATE AND TRETINOIN

GEL;TOPICAL; 1.2%;0.025%
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE AND TRETINOIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	No	AB2	216943	ENCUBE
CLINDAMYCIN PHOSPHATE AND TRETINOIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	No	AB2	212845	SOLARIS PHARMA CORP
VELTIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	Yes	AB2	050803	ALMIRALL