Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 204141
Company: TARO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT DESOXIMETASONE 0.25% SPRAY;TOPICAL Prescription AT 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
04/11/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204141Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141_topicort_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204141Orig1s004ltr.pdf
09/23/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/18/2014 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
12/16/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf
04/11/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf

TOPICORT

SPRAY;TOPICAL; 0.25%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESOXIMETASONE DESOXIMETASONE 0.25% SPRAY;TOPICAL Prescription No AT 208124 LUPIN ATLANTIS
DESOXIMETASONE DESOXIMETASONE 0.25% SPRAY;TOPICAL Prescription No AT 206441 PERRIGO ISRAEL
TOPICORT DESOXIMETASONE 0.25% SPRAY;TOPICAL Prescription Yes AT 204141 TARO PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English