Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075500
Company: AIPING PHARM INC
Company: AIPING PHARM INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SORINE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | AB | No | No |
SORINE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | AB | No | No |
SORINE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL | Prescription | AB | No | No |
SORINE | SOTALOL HYDROCHLORIDE | 120MG | 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 |
---|---|---|---|---|---|---|---|
04/27/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75500ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/04/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
03/02/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
03/02/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
05/13/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/19/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
SORINE
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 |