اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BETAPACE از شرکت COVIS
New Drug Application (NDA): 019865
Company: COVIS
| 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 |
|---|---|---|---|---|---|
| 06/03/2021 | SUPPL-22 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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. |
||
| 07/26/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 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 |
|---|---|---|---|---|---|
| 06/03/2021 | 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 | COVIS |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | COVIS |
| SORINE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 075500 | UPSHER SMITH LABS |
| 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 | 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 INC |
| 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 | COVIS |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | COVIS |
| SORINE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 075500 | UPSHER SMITH LABS |
| 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 | 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 INC |
| 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 | COVIS |
| SORINE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | No | AB | 075500 | UPSHER SMITH LABS |
| 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 | COVIS |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | COVIS |
| SORINE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 075500 | UPSHER SMITH LABS |
| 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 | 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 INC |
| 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 |
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