Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074904
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPICORT DESOXIMETASONE 0.05% GEL;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
07/14/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74904ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74904ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074904Orig1s015ltr.pdf
11/23/2004 SUPPL-8 Labeling

Label is not available on this site.

12/19/2003 SUPPL-7 Labeling

Label is not available on this site.

07/24/2003 SUPPL-5 Labeling

Label is not available on this site.

11/04/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/07/1999 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
01/05/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf

TOPICORT

GEL;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% GEL;TOPICAL Prescription No AB 090727 AKORN
DESOXIMETASONE DESOXIMETASONE 0.05% GEL;TOPICAL Prescription No AB 204675 ANDA REPOSITORY
DESOXIMETASONE DESOXIMETASONE 0.05% GEL;TOPICAL Prescription No AB 077552 PERRIGO NEW YORK
TOPICORT DESOXIMETASONE 0.05% GEL;TOPICAL Prescription No AB 074904 TARO PHARM INDS LTD

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