Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019260
Company: PHARMACIA AND UPJOHN
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

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