Application 202289
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 12.5MG;50MG | No | No |
| 002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 12.5MG;100MG | 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-050 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-050 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-050 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-051 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-051 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-051 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-052 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-052 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-052 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | Macleods Pharmaceuticals Limited | ANDA | Current |
| 70518-3231 | Losartan potassium and Hydrochlorothiazide | Losartan potassium and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 72189-289 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | DirectRx | ANDA | Current |
| 72189-290 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | DirectRx | ANDA | Current |
| 72189-297 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | DirectRx | ANDA | Current |