Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012657
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CELESTONE | BETAMETHASONE | 0.6MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/1961 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 11/19/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/07/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 08/10/1994 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 12/17/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/02/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1986 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/23/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1983 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/30/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1981 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/03/1979 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/08/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |