Drugs@FDA: FDA-Approved Drugs
Company: LEGACY PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETAPACE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | AB | Yes | No |
BETAPACE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
BETAPACE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | AB | Yes | No |
BETAPACE | SOTALOL HYDROCHLORIDE | 320MG | TABLET;ORAL | Discontinued | None | No | No |
BETAPACE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
10/30/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/15/2023 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019865Orig1s026Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019865Orig1s026Corrected_ltr.pdf | |
06/03/2021 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019865Orig1s022ltr.pdf | |
05/10/2016 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019865Orig1s021ltr.pdf | |
08/17/2011 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s020ltr.pdf | |
02/03/2011 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s019ltr.pdf | |
07/26/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/22/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/07/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
10/01/2001 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865s10_Betapace.cfm | |
04/09/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/23/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
12/04/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/26/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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04/20/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
09/06/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/20/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/13/1993 | 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 |
---|---|---|---|---|---|
06/15/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019865Orig1s026Corrected_lbl.pdf | |
06/03/2021 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf | |
05/10/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf | |
08/17/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf | |
02/03/2011 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf | |
10/01/2001 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf |
BETAPACE
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; 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 |
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 |