Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | EQ 0.1% PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC, OTIC | 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 |
|---|---|---|---|---|---|---|---|
| 09/02/1959 | 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 |
|---|---|---|---|---|---|
| 07/31/1997 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/29/1997 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/04/1997 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/02/1996 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/16/1996 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1995 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/22/1994 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/21/1994 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 04/18/1991 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 02/16/1988 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1988 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 02/16/1988 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 02/25/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1988 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 12/06/1984 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1986 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/14/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/15/1982 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 02/16/1988 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 10/27/1981 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/09/1981 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/01/1980 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/15/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/28/1980 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 08/26/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 01/08/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 05/19/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/21/1976 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |