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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017994
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PSORCON E DIFLORASONE DIACETATE 0.05% OINTMENT;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
03/01/1978 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-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017994s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017741Orig1s024,017994Orig1s026,019259Orig1s012,019260Orig1s009ltr.pdf
05/30/2003 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17994slr022_psorcon_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17994slr022ltr.pdf
01/21/1999 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/10/1997 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/03/1988 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
01/03/1986 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
05/31/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
03/29/1984 SUPPL-16 Labeling

Label is not available on this site.
11/04/1983 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/20/1982 SUPPL-14 Labeling

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

Label is not available on this site.
05/05/1981 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
06/25/1981 SUPPL-11 Labeling

Label is not available on this site.
02/18/1981 SUPPL-9 Labeling

Label is not available on this site.
01/16/1981 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
07/16/1979 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/16/1979 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/16/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
05/22/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/17/1979 SUPPL-3 Manufacturing (CMC)-Control

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

Label is not available on this site.
01/10/1979 SUPPL-1 Manufacturing (CMC)-Control

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-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017994s026lbl.pdf
05/30/2003 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17994slr022_psorcon_lbl.pdf
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