Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
12/17/2003 | 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 |
---|---|---|---|---|---|
02/25/2020 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/25/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/07/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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11/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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07/14/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/28/2006 | SUPPL-7 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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02/28/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/28/2006 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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11/23/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/28/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/28/2006 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |