Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202161
Company: TARO

Products on ANDA 202161

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202161

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202161Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 202161

DESONIDE

LOTION;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%	LOTION;TOPICAL	Prescription	No	AB	213632	ALEMBIC
DESONIDE	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	075860	FOUGERA PHARMS
DESONIDE	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	209494	GLENMARK PHARMS
DESONIDE	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	202161	TARO
DESOWEN	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	072354	GALDERMA LABS LP