Drugs@FDA: FDA Approved Drug Products
Company: ZYDUS PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2008 | 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 |
|---|---|---|---|---|---|
| 10/29/2019 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2013 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2010 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
AMIODARONE HYDROCHLORIDE
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204742 | AUROBINDO PHARMA LTD |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075389 | MAYNE PHARMA INC |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 077069 | MURTY PHARMS |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 078578 | RUBICON |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075315 | SANDOZ |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075424 | TARO |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 074739 | TEVA PHARMS |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 079029 | ZYDUS PHARMS USA INC |
| PACERONE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075135 | UPSHER SMITH LABS |
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