Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050803
Company: ALMIRALL

• Summary Review

Products on NDA 050803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VELTIN	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL;TOPICAL	Prescription	AB2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050803s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050803s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803s000_veltin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803Orig1s000SumR.pdf

Labels for NDA 050803

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050803s000lbl.pdf

Therapeutic Equivalents for NDA 050803

VELTIN

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