Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEODECADRON | DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE | EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM | 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 |
|---|---|---|---|---|---|---|---|
| 09/15/1969 | ORIG-1 | Approval |
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-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/06/1984 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1982 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 10/13/1981 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/29/1981 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1981 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1981 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/28/1980 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1978 | SUPPL-20 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/23/1977 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/23/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1976 | SUPPL-17 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/07/1975 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/18/1973 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/07/1972 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/31/1972 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/20/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/11/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/20/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/15/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1970 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/24/1969 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/06/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1984 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/03/1969 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/28/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |