Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075135
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PACERONE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL | Prescription | AB | No | No |
| PACERONE | AMIODARONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| PACERONE | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2019 | SUPPL-54 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/01/2019 | SUPPL-52 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/01/2019 | SUPPL-51 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/01/2019 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-48 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-47 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2013 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2013 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2010 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2009 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2009 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 11/01/2019 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 11/16/2007 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/01/2019 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/01/2019 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/04/2006 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/13/2006 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/04/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/05/2004 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/24/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/12/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/19/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/20/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-7 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf |
| 04/12/2000 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf |
| 04/12/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf |
| 02/01/2000 | SUPPL-4 | Bioequivalence |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf |
| 09/24/1999 | SUPPL-3 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf |
| 12/02/1999 | SUPPL-2 | Manufacturing (CMC)-Facility |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf |
| 12/02/1999 | SUPPL-1 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf |
PACERONE
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 |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 077069 | CHARTWELL RX |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075389 | DR REDDYS LABS SA |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 078578 | RUBICON |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075424 | TARO |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 079029 | ZYDUS PHARMS USA INC |
| PACERONE | AMIODARONE HYDROCHLORIDE | 100MG | 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 | 077069 | CHARTWELL RX |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 075389 | DR REDDYS LABS SA |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 078578 | RUBICON |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 076362 | TARO |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 079029 | ZYDUS PHARMS USA INC |
| PACERONE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 075135 | UPSHER SMITH LABS |