Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207955
Company: MYLAN

Products on ANDA 207955

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	0.05%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207955

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2015	ORIG-1	Approval		STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207955Orig1s000.pdf

Therapeutic Equivalents for ANDA 207955

TRETINOIN

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATRALIN	TRETINOIN	0.05%	GEL;TOPICAL	Prescription	Yes	AB	022070	DOW PHARM
TRETINOIN	TRETINOIN	0.05%	GEL;TOPICAL	Prescription	No	AB	207955	MYLAN