Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HUMORSOL | DEMECARIUM BROMIDE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | No | No |
| HUMORSOL | DEMECARIUM BROMIDE | 0.125% | SOLUTION/DROPS;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 |
|---|---|---|---|---|---|---|---|
| 08/05/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 04/15/1998 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/29/1998 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/04/1997 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/20/1997 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/30/1997 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/16/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1995 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/22/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 04/23/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/13/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/14/1984 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/27/1981 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/13/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/06/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/15/1981 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/05/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/21/1976 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/22/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |