Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091497
Company: PRINSTON INC
Company: PRINSTON INC
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 |
---|---|---|---|---|---|---|---|
06/06/2011 | 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 |
---|---|---|---|---|---|
04/12/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/12/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
02/13/2015 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/11/2014 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/11/2014 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/19/2012 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 |