Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075187
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% CREAM;TOPICAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75187ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/12/2005 SUPPL-7 Labeling

Label is not available on this site.

10/02/2003 SUPPL-3 Labeling

Label is not available on this site.

08/19/2003 SUPPL-1 Labeling

Label is not available on this site.

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