Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077666
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | AB | No | No |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | AB | No | No |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/22/2007 | 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 |
|---|---|---|---|---|---|
| 01/07/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/03/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2013 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2013 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/06/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
MIRTAZAPINE
TABLET;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;ORAL | Prescription | No | AB | 219721 | ANNORA PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076219 | CHARTWELL RX |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 220104 | MICRO LABS |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 219919 | NOVITIUM PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |
| REMERON | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 020415 | ORGANON |
TABLET;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;ORAL | Prescription | No | AB | 219721 | ANNORA PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076219 | CHARTWELL RX |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 220104 | MICRO LABS |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 219919 | NOVITIUM PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |
| REMERON | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 020415 | ORGANON |
TABLET;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;ORAL | Prescription | No | AB | 219721 | ANNORA PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076219 | CHARTWELL RX |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 220104 | MICRO LABS |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 219919 | NOVITIUM PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |