Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019408
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPROLENE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | CREAM, AUGMENTED;TOPICAL | Discontinued | None | No | No |
| DIPROLENE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | GEL, AUGMENTED;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 |
|---|---|---|---|---|---|---|---|
| 01/31/1986 | 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 |
|---|---|---|---|---|---|
| 12/07/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/14/1999 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/10/1998 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/15/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/31/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/15/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/30/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/08/1993 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/22/1991 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/01/1990 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/24/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 02/24/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |