Drugs@FDA: FDA-Approved Drugs
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FLORONE | DIFLORASONE DIACETATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | No | No |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. |
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05/17/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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05/30/1989 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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03/02/1988 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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03/29/1984 | SUPPL-14 | Labeling |
Label is not available on this site. |
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08/20/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
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08/20/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
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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. |
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02/18/1981 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/18/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
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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. |
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07/16/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
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11/07/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |
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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 |