Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210747
Company: COSETTE

Products on ANDA 210747

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210747

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210747

FLUOCINOLONE ACETONIDE

CREAM;TOPICAL; 0.025%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	210747	COSETTE
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	088169	FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	087104	TARO
SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	Yes	AT	012787	MEDIMETRIKS PHARMS