Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205798
Company: SQUARE PHARMS
Company: SQUARE PHARMS
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 |
---|---|---|---|---|---|---|---|
06/01/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/06/2023 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/16/2020 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
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 |