Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076312
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Discontinued | None | No | No |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/19/2003 | 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 |
|---|---|---|---|---|---|
| 10/23/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/24/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/02/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 06/03/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/06/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 01/29/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/23/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/21/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |