Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017536
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPROSONE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE 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
01/29/1975 ORIG-1 Approval Type 2 - New Active Ingredient 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
01/10/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-24 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17536s18ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-536S018_Diprosone.cfm
05/14/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1998 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1998 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17536s18ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-536S018_Diprosone.cfm
08/01/1990 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/12/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/12/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/19/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/21/1982 SUPPL-9 Efficacy

Label is not available on this site.

09/02/1981 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/13/1981 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/26/1979 SUPPL-5 Labeling

Label is not available on this site.

07/06/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1978 SUPPL-2 Labeling

Label is not available on this site.

03/17/1975 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/2001/17536s18lbl.pdf
10/03/2001 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17536s18lbl.pdf

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