Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012376
Company: MERCK
Company: MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DECADRON | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
07/07/1960 | 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 |
---|---|---|---|---|---|
08/27/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
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01/12/1989 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/16/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
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02/10/1982 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/21/1982 | SUPPL-18 | Labeling |
Label is not available on this site. |
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08/15/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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03/01/1979 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |