Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076346
Company: PLIVA PHARM IND
Company: PLIVA PHARM IND
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | AB | No | Yes |
TORSEMIDE | TORSEMIDE | 100MG | 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 |
---|---|---|---|---|---|---|---|
05/30/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/04/2020 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
12/12/2012 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
09/21/2011 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
10/19/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
10/19/2004 | SUPPL-6 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/05/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
TORSEMIDE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078249 | AUROBINDO PHARMA |
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076894 | COREPHARMA |
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 079234 | HETERO LABS LTD III |
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076943 | HIKMA |
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076346 | PLIVA PHARM IND |
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076226 | STRIDES PHARMA |
TORSEMIDE | TORSEMIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090613 | STRIDES PHARMA |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078249 | AUROBINDO PHARMA |
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076894 | COREPHARMA |
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 079234 | HETERO LABS LTD III |
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076943 | HIKMA |
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076346 | PLIVA PHARM IND |
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076226 | STRIDES PHARMA |
TORSEMIDE | TORSEMIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090613 | STRIDES PHARMA |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078249 | AUROBINDO PHARMA |
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076894 | COREPHARMA |
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 079234 | HETERO LABS LTD III |
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076943 | HIKMA |
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076346 | PLIVA PHARM IND |
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076226 | STRIDES PHARMA |
TORSEMIDE | TORSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 090613 | STRIDES PHARMA |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TORSEMIDE | TORSEMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 078249 | AUROBINDO PHARMA |
TORSEMIDE | TORSEMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076894 | COREPHARMA |
TORSEMIDE | TORSEMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 079234 | HETERO LABS LTD III |
TORSEMIDE | TORSEMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076346 | PLIVA PHARM IND |
TORSEMIDE | TORSEMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076226 | STRIDES PHARMA |
TORSEMIDE | TORSEMIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 090613 | STRIDES PHARMA |