Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085253
Company: ABC HOLDING
Company: ABC HOLDING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/07/1977 | 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 |
|---|---|---|---|---|---|
| 11/16/1990 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/27/1988 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1983 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1983 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |