Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074286
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT DESOXIMETASONE 0.25% OINTMENT;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
06/07/1996 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
03/20/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/074286Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/074286Orig1s017ltr.pdf
03/15/2010 SUPPL-16 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/074286Orig1s016.pdf
04/15/2015 SUPPL-15 Labeling

Label is not available on this site.

07/25/2008 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s013.pdf
07/25/2008 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s012.pdf
09/15/2005 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/074286Orig1s010.pdf
11/23/2004 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s009.pdf
04/26/2004 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s008.pdf
04/26/2004 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s007.pdf
12/19/2003 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/074286Orig1s006.pdf
05/16/2000 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074286Orig1s004.pdf
04/09/1999 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074286Orig1s003.pdf
07/18/1997 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/074286Orig1s002.pdf
09/17/1996 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1996/074286Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/20/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/074286Orig1s017lbl.pdf

TOPICORT

OINTMENT;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% OINTMENT;TOPICAL Prescription No AB 206740 ACP NIMBLE
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 204965 ACTAVIS MID ATLANTIC
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 201005 AKORN
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 204272 ANDA REPOSITORY
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 078657 FOUGERA PHARMS
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 202838 GLENMARK GENERICS
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 208104 LUPIN ATLANTIS
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 206792 NOVEL LABS INC
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 077770 PERRIGO ISRAEL
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 208101 TELIGENT PHARMA INC
DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 205206 ZYDUS PHARMS
TOPICORT DESOXIMETASONE 0.25% OINTMENT;TOPICAL Prescription No AB 074286 TARO PHARM INDS LTD

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