Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011977
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | EQ 0.05% PHOSPHATE | OINTMENT;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 09/02/1959 | 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 |
|---|---|---|---|---|---|
| 04/16/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/10/1995 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/30/1994 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/21/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 12/28/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/25/1990 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 12/07/1987 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 05/30/1989 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/15/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/15/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 05/29/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 06/24/1981 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/10/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/19/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |