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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018594
Company: TARO

Products on NDA 018594

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPICORT	DESOXIMETASONE	0.05%	OINTMENT;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/1985	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/26/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/26/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/12/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/07/2012	SUPPL-8	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018594Orig1s008ltr.pdf
05/14/2010	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018594s007ltr.pdf
07/26/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/13/1993	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/1988	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/19/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018594

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2012	SUPPL-8	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf
05/14/2010	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf

Therapeutic Equivalents for NDA 018594

TOPICORT

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOXIMETASONE	DESOXIMETASONE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	208044	LUPIN
DESOXIMETASONE	DESOXIMETASONE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	209973	THE J MOLNER
TOPICORT	DESOXIMETASONE	0.05%	OINTMENT;TOPICAL	Prescription	Yes	AB	018594	TARO

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