Drugs@FDA: FDA Approved Drug Products
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | AB | No | Yes |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/23/1998 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75315ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075315_amiodarone_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/24/2015 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2015 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2015 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2015 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2013 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2010 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/17/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/30/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/10/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/28/2006 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/28/2006 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/18/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/29/2004 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/04/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/24/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/26/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf |
| 01/11/2000 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s005,006,007ltr.pdf |
| 06/30/2000 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf |
| 06/30/2000 | SUPPL-4 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75315S4,5ltr.pdf |
| 02/02/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/21/1999 | 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 |
TABLET;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 075389 | MAYNE PHARMA INC |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 077069 | MURTY PHARMS |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 075315 | SANDOZ |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 076362 | TARO |
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