Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018389
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALDOMET | METHYLDOPA | 250MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 08/28/1981 | 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 |
|---|---|---|---|---|---|
| 08/05/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/16/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/13/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/11/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/22/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/22/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/05/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/23/1983 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/11/1987 | SUPPL-1 | Labeling |
Label is not available on this site. |