Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204038
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
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 |
---|---|---|---|---|---|---|---|
10/27/2021 | ORIG-1 | Approval |
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 | 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 | 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 | 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 | 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 |