Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209729
Company: GLENMARK PHARMS

Products on ANDA 209729

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 209729

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209729

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