Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078245
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | AB | No | No |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | AB | No | No |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;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 |
|---|---|---|---|---|---|---|---|
| 10/06/2010 | ORIG-2 | Approval |
Label is not available on this site. |
||||
| 05/21/2010 | 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 |
|---|---|---|---|---|---|
| 07/31/2023 | SUPPL-40 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/14/2022 | SUPPL-31 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2022 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2022 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/25/2017 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2015 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2015 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/28/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2013 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/05/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2011 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 12.5MG;50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYZAAR | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | Yes | AB | 020387 | ORGANON |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 091617 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 091629 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 201682 | IPCA LABS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 201845 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 078245 | LUPIN LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 202289 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 204901 | PRINSTON INC |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 077948 | SANDOZ |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 077157 | TEVA PHARMS |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 204832 | UNICHEM |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Prescription | No | AB | 078385 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 12.5MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYZAAR | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 020387 | ORGANON |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 091617 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 091629 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 201682 | IPCA LABS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 201845 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 078245 | LUPIN LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 202289 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 204901 | PRINSTON INC |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 077948 | SANDOZ |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 077157 | TEVA PHARMS |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Prescription | No | AB | 204832 | UNICHEM |
TABLET;ORAL; 25MG;100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYZAAR | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 020387 | ORGANON |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 091617 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 091629 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 201682 | IPCA LABS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 201845 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 078245 | LUPIN LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 202289 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 204901 | PRINSTON INC |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 077948 | SANDOZ |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 077157 | TEVA PHARMS |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 204832 | UNICHEM |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 078385 | ZYDUS PHARMS USA INC |