Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074027
Company: COSETTE

Products on ANDA 074027

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074027

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/1992	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/23/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074027

DESONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	214396	ALEMBIC
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	210198	CADILA
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	074027	COSETTE
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	209729	GLENMARK PHARMS
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	Yes	AB	017010	PADAGIS US
DESONIDE	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	073548	TARO
DESOWEN	DESONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB	019048	GALDERMA LABS LP