Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073210
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT DESOXIMETASONE 0.05% CREAM;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/1990 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
06/19/2014 SUPPL-31 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/11/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073210Orig1s029Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073210Orig1s029ltr.pdf
12/30/2011 SUPPL-27 Labeling

Label is not available on this site.

11/23/2004 SUPPL-17 Labeling

Label is not available on this site.

02/19/2004 SUPPL-16 Labeling

Label is not available on this site.

12/19/2003 SUPPL-15 Labeling

Label is not available on this site.

06/20/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/09/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/15/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/11/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073210Orig1s029Lbl.pdf

TOPICORT

CREAM;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% CREAM;TOPICAL Prescription No AB 203787 AKORN
DESOXIMETASONE DESOXIMETASONE 0.05% CREAM;TOPICAL Prescription No AB 210980 ANDA REPOSITORY
DESOXIMETASONE DESOXIMETASONE 0.05% CREAM;TOPICAL Prescription No AB 208163 LUPIN ATLANTIS
TOPICORT DESOXIMETASONE 0.05% CREAM;TOPICAL Prescription No AB 073210 TARO PHARM INDS LTD

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