Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215959
Company: GRANULES
Company: GRANULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | AB | No | No |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | AB | No | No |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 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 |
---|---|---|---|---|---|---|---|
02/23/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LOSARTAN POTASSIUM
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COZAAR | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | Yes | AB | 020386 | ORGANON |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 090428 | ALEMBIC PHARMS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 218551 | APOTEX |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 090083 | AUROBINDO PHARMA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 077424 | CHARTWELL RX |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 215959 | GRANULES |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 203835 | HETERO LABS LTD V |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 200290 | IPCA LABS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 201170 | JUBILANT CADISTA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 078232 | LUPIN LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 202230 | MACLEODS PHARMS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 091541 | MICRO LABS |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 217396 | MSN |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 091497 | PRINSTON INC |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 090382 | STRIDES PHARMA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 203030 | UNICHEM |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 091129 | WATSON LABS |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 078243 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COZAAR | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | Yes | AB | 020386 | ORGANON |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 090428 | ALEMBIC PHARMS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 218551 | APOTEX |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 090083 | AUROBINDO PHARMA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 077424 | CHARTWELL RX |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215959 | GRANULES |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 203835 | HETERO LABS LTD V |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 200290 | IPCA LABS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 201170 | JUBILANT CADISTA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 078232 | LUPIN LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 202230 | MACLEODS PHARMS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 091541 | MICRO LABS |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 217396 | MSN |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 091497 | PRINSTON INC |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 090382 | STRIDES PHARMA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 203030 | UNICHEM |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 091129 | WATSON LABS |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 078243 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COZAAR | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020386 | ORGANON |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090428 | ALEMBIC PHARMS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 218551 | APOTEX |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090083 | AUROBINDO PHARMA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 077424 | CHARTWELL RX |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 215959 | GRANULES |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 203835 | HETERO LABS LTD V |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 200290 | IPCA LABS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 201170 | JUBILANT CADISTA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 078232 | LUPIN LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 202230 | MACLEODS PHARMS LTD |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091541 | MICRO LABS |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 217396 | MSN |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091497 | PRINSTON INC |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090382 | STRIDES PHARMA |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 203030 | UNICHEM |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091129 | WATSON LABS |
LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 078243 | ZYDUS PHARMS USA INC |