Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076921
Company: AUROBINDO
Company: AUROBINDO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET;ORAL | Prescription | AB | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 10/22/2004 | 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 |
|---|---|---|---|---|---|
| 09/15/2022 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2021 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2021 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2015 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/30/2010 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2011 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/26/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/26/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/21/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/16/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/09/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/21/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/28/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
MIRTAZAPINE
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
| MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
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 | 076219 | AIPING PHARM INC |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| 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 | 076219 | AIPING PHARM INC |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| 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 | 076219 | AIPING PHARM INC |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| 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 |