Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201677
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | AB | No | No |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | AB | No | No |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | AB | No | No |
| VALSARTAN | VALSARTAN | 320MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/05/2015 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/03/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/03/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
VALSARTAN
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 077530 | IVAX PHARMS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 077530 | IVAX PHARMS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |
TABLET;ORAL; 160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 077530 | IVAX PHARMS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |
TABLET;ORAL; 320MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIOVAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | Yes | AB | 021283 | NOVARTIS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 091367 | ALEMBIC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 205536 | ALKEM LABS LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 204011 | AMNEAL PHARMS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 202223 | AUROBINDO PHARMA LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 201618 | DR REDDYS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 203311 | HETERO LABS LTD V |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 077530 | IVAX PHARMS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 203536 | JUBILANT GENERICS |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 201677 | LUPIN LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 202696 | MACLEODS PHARMS LTD |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 090866 | MYLAN |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 077492 | OHM LABS INC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 204821 | PRINSTON INC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 204038 | SCIEGEN PHARMS INC |
| VALSARTAN | VALSARTAN | 320MG | TABLET;ORAL | Prescription | No | AB | 205347 | SQUARE PHARMS |