Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076362
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/29/2002 | 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 |
|---|---|---|---|---|---|
| 06/23/2020 | SUPPL-25 | Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/15/2019 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/15/2019 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2019 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2015 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/19/2015 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2014 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/04/2010 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/02/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/05/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/07/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/02/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/03/2003 | SUPPL-1 |
Label is not available on this site. |