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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204141
Company: TARO

Summary Review

Products on NDA 204141

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPICORT	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204141

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204141Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141_topicort_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2021	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204141s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204141Orig1s009ltr.pdf
12/16/2015	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204141Orig1s004ltr.pdf
09/23/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/10/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/18/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204141

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2021	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204141s009lbl.pdf
12/16/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf
04/11/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf

Therapeutic Equivalents for NDA 204141

TOPICORT

SPRAY;TOPICAL; 0.25%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOXIMETASONE	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	No	AT	208124	LUPIN
DESOXIMETASONE	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	No	AT	206441	PADAGIS ISRAEL
TOPICORT	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	Yes	AT	204141	TARO

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