Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078385
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| 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 | 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-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 |
|---|---|---|---|---|---|
| 02/24/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/15/2016 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2013 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/20/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/08/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/21/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2010 | SUPPL-1 | Labeling-Package Insert |
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; 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 |