Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075508
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% CREAM;TOPICAL Prescription BX 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
04/24/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75508ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2016 SUPPL-14 Labeling-Proprietary Name Change

Label is not available on this site.

07/28/2016 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/15/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

DIFLORASONE DIACETATE

There are no Therapeutic Equivalents.

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