Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017691
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPROSONE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE 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
04/15/1976 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
10/03/2001 SUPPL-24 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17691s19ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-691S019_Diprosone.cfm
11/10/1998 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1998 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1998 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17691s19ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-691S019_Diprosone.cfm
07/05/1990 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1990 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1984 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1984 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/21/1982 SUPPL-10 Efficacy

Label is not available on this site.

09/02/1981 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/26/1979 SUPPL-7 Labeling

Label is not available on this site.

08/29/1979 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/20/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1979 SUPPL-3 Labeling

Label is not available on this site.

09/06/1977 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/1976 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
10/03/2001 SUPPL-24 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf
10/03/2001 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17691s19lbl.pdf

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