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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017741
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLORONE DIFLORASONE DIACETATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;TOPICAL Discontinued None No No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
09/14/1977 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017741s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf
12/18/2003 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr022_florone_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17741slr022ltr.pdf
05/29/2003 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17741slr021ltr.pdf
10/10/1997 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/17/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
05/30/1989 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
03/02/1988 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
03/29/1984 SUPPL-14 Labeling

Label is not available on this site.
08/20/1982 SUPPL-13 Labeling

Label is not available on this site.
08/20/1982 SUPPL-12 Labeling

Label is not available on this site.
10/21/1981 SUPPL-11 Labeling

Label is not available on this site.
05/05/1981 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
02/18/1981 SUPPL-8 Labeling

Label is not available on this site.
02/18/1981 SUPPL-7 Labeling

Label is not available on this site.
01/16/1981 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
05/22/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/24/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
07/16/1979 SUPPL-3 Labeling

Label is not available on this site.
11/07/1978 SUPPL-2 Labeling

Label is not available on this site.
02/04/1981 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/25/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017741s024lbl.pdf
12/18/2003 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr022_florone_lbl.pdf
05/29/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17741slr021lbl.pdf
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