Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085269
Company: ANI PHARMS
Company: ANI PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 11/11/1976 | 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 |
|---|---|---|---|---|---|
| 06/15/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/28/1989 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/14/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |