Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 11/30/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74739ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2020 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2020 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2020 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2015 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2015 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2015 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2011 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2010 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/16/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/14/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/12/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/30/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/30/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/07/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/04/2006 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/11/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/24/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/29/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/26/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/30/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-739_Amiodarone_prntlbl.pdf |
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 | 077069 | CHARTWELL RX |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 075389 | DR REDDYS LABS SA |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 078578 | RUBICON |
| 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 | 213446 | UNICHEM |
| 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 |