Drugs@FDA: FDA-Approved Drugs
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 |