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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073193
Company: TARO

Products on ANDA 073193

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPICORT	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073193

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/1990	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/03/2012	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073193SOrig1s33Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073193Orig1s033ltr.pdf
02/29/2008	SUPPL-27	Labeling		Label is not available on this site.
11/23/2004	SUPPL-22	Labeling		Label is not available on this site.
02/19/2004	SUPPL-21	Labeling		Label is not available on this site.
12/19/2003	SUPPL-20	Labeling		Label is not available on this site.
06/20/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
05/03/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/09/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 073193

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/03/2012	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073193SOrig1s33Lbl.pdf

Therapeutic Equivalents for ANDA 073193

TOPICORT

CREAM;TOPICAL; 0.25%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	205082	ACTAVIS MID ATLANTIC
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	078369	FOUGERA PHARMS
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	208164	LUPIN
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	076510	PADAGIS ISRAEL
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	205594	RISING
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	203234	SCIEGEN PHARMS
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	205620	ZYDUS LIFESCIENCES
TOPICORT	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	073193	TARO

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