Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/28/2006 | ORIG-2 | Approval | Labeling |
Label is not available on this site. |
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12/08/2005 | 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 |
---|---|---|---|---|---|
08/16/2021 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/16/2021 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/15/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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11/15/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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11/15/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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01/16/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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04/19/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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04/19/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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06/28/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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10/30/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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10/30/2007 | 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) |
Label is not available on this site. |
MIRTAZAPINE
TABLET, ORALLY DISINTEGRATING;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077376 | AUROBINDO PHARMA |
MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205798 | SQUARE PHARMS |
REMERON SOLTAB | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021208 | ORGANON USA ORGANON |
TABLET, ORALLY DISINTEGRATING;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077376 | AUROBINDO PHARMA |
MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205798 | SQUARE PHARMS |
REMERON SOLTAB | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021208 | ORGANON USA ORGANON |
TABLET, ORALLY DISINTEGRATING;ORAL; 45MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077376 | AUROBINDO PHARMA |
MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205798 | SQUARE PHARMS |
REMERON SOLTAB | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021208 | ORGANON USA ORGANON |