Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073193
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT DESOXIMETASONE 0.25% 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
11/29/1990 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.

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

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 203234 AKORN
DESOXIMETASONE DESOXIMETASONE 0.25% CREAM;TOPICAL Prescription No AB 205594 ANDA REPOSITORY
DESOXIMETASONE DESOXIMETASONE 0.25% CREAM;TOPICAL Prescription No AB 078369 FOUGERA PHARMS
DESOXIMETASONE DESOXIMETASONE 0.25% CREAM;TOPICAL Prescription No AB 208164 LUPIN ATLANTIS
DESOXIMETASONE DESOXIMETASONE 0.25% CREAM;TOPICAL Prescription No AB 076510 PERRIGO NEW YORK
TOPICORT DESOXIMETASONE 0.25% CREAM;TOPICAL Prescription No AB 073193 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