Application 077732
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 12.5MG;100MG | No | No |
| 002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 12.5MG;50MG | No | No |
| 003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 25MG;100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0126 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0127 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0277 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 33261-904 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Aidarex Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31284 | ORIG | 2010-04-09 |