Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017781
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPROSONE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** LOTION;TOPICAL Discontinued None Yes No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
02/01/1977 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
05/11/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2001 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17781s15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-781S015_Diprosone.cfm
09/07/2000 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1999 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.

07/31/1998 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1997 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/03/2001 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17781s15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/17-781S015_Diprosone.cfm
08/08/1995 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1990 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1989 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1982 SUPPL-9 Labeling

Label is not available on this site.

04/19/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/02/1981 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/15/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1980 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/06/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1980 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-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf
10/03/2001 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17781s15lbl.pdf

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