Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018594
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT DESOXIMETASONE 0.05% OINTMENT;TOPICAL Prescription AB Yes 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
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.

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

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 ATLANTIS
DESOXIMETASONE DESOXIMETASONE 0.05% OINTMENT;TOPICAL Prescription No AB 209973 TELIGENT PHARMA INC
TOPICORT DESOXIMETASONE 0.05% OINTMENT;TOPICAL Prescription Yes AB 018594 TARO PHARM INDS LTD

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