Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076241
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
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 |
---|---|---|---|---|---|---|---|
06/25/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076241.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/11/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
10/30/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/23/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
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07/21/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/12/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/29/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/22/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |