Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088732
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 |
|---|---|---|---|---|---|---|---|
| 12/11/1985 | 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 |
|---|---|---|---|---|---|
| 07/07/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/29/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/07/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/25/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |