Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016322
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALISONE | BETAMETHASONE VALERATE | EQ 0.1% BASE | CREAM;TOPICAL | Discontinued | None | No | No |
| VALISONE | BETAMETHASONE VALERATE | EQ 0.01% 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 |
|---|---|---|---|---|---|---|---|
| 09/02/1967 | 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 |
|---|---|---|---|---|---|
| 11/08/1991 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/12/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/20/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/23/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1984 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/05/1983 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/16/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1981 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 08/13/1981 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 12/26/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/31/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/03/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/12/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/26/1977 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |