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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074904
Company: TARO

Products on ANDA 074904

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPICORT	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074904

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74904ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74904ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2012	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074904Orig1s015ltr.pdf
11/23/2004	SUPPL-8	Labeling		Label is not available on this site.
12/19/2003	SUPPL-7	Labeling		Label is not available on this site.
07/24/2003	SUPPL-5	Labeling		Label is not available on this site.
11/04/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
04/09/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/07/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 074904

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2012	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf

Therapeutic Equivalents for ANDA 074904

TOPICORT

GEL;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%	GEL;TOPICAL	Prescription	No	AB	090727	EPIC PHARMA LLC
DESOXIMETASONE	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	No	AB	204675	RISING
TOPICORT	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	No	AB	074904	TARO

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