Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012071
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/06/1959 | 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 |
|---|---|---|---|---|---|
| 02/18/2000 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/22/1997 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/09/1997 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/17/1999 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/01/1996 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1993 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 12/11/1989 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/08/1985 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 06/25/1984 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1979 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 10/18/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 02/05/1981 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |