Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019260
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PSORCON | DIFLORASONE DIACETATE | 0.05% | OINTMENT;TOPICAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
08/28/1985 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019260s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf | |
04/24/2003 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019260s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19260slr007ltr.pdf | |
10/10/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/17/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/25/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/14/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/12/1986 | SUPPL-1 | Manufacturing (CMC)-Packaging |
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-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019260s009lbl.pdf | |
04/24/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019260s007lbl.pdf |