Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201170
Company: JUBILANT CADISTA
Company: JUBILANT CADISTA
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 |
---|---|---|---|---|---|---|---|
09/18/2012 | 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 |
---|---|---|---|---|---|
07/05/2019 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
08/28/2018 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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06/10/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/10/2015 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
04/10/2015 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/31/2015 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/10/2015 | SUPPL-1 | 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 |