Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075429
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | AB | No | No |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | AB | No | No |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | AB | No | No |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/01/2000 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75429ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75429ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2022 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/24/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2011 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/26/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/03/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/13/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/01/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-429_Sotalol%20Hydrochloride_prntlbl.pdf |
SOTALOL HYDROCHLORIDE
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | Yes | AB | 019865 | LEGACY PHARMA |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | LEGACY PHARMA |
| SORINE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 075500 | AIPING PHARM INC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 076140 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 076214 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 077616 | AUROBINDO PHARMA USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 207428 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 207429 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 077070 | EPIC PHARMA LLC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 075563 | OXFORD PHARMS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 075429 | TEVA |
TABLET;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 019865 | LEGACY PHARMA |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | LEGACY PHARMA |
| SORINE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 075500 | AIPING PHARM INC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 076140 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 076214 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 077616 | AUROBINDO PHARMA USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 207428 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 207429 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 077070 | EPIC PHARMA LLC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 075563 | OXFORD PHARMS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 075429 | TEVA |
TABLET;ORAL; 160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | Yes | AB | 019865 | LEGACY PHARMA |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | LEGACY PHARMA |
| SORINE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 075500 | AIPING PHARM INC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 076140 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 076214 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 077616 | AUROBINDO PHARMA USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 207428 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 207429 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 077070 | EPIC PHARMA LLC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 075563 | OXFORD PHARMS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 075429 | TEVA |
TABLET;ORAL; 240MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | Yes | AB | 019865 | LEGACY PHARMA |
| SORINE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | No | AB | 075500 | AIPING PHARM INC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | No | AB | 076140 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | No | AB | 075563 | OXFORD PHARMS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | No | AB | 075429 | TEVA |