Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084657
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 12/01/1975 | 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 |
|---|---|---|---|---|---|
| 09/14/2021 | SUPPL-54 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 03/19/1987 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/21/1986 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/21/1986 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1982 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |