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| BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |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. |
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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. |
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06/15/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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. |
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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. |
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12/02/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
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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. |
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07/06/1979 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/12/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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 |