Application 078245
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | |
| A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | |
| A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078245-001 | AB |
| A078245-002 | AB |
| A078245-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-05-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078245-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078245-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078245-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078245-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078245-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078245-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078245-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078245-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078245-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078245-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078245-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078245-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078245-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078245-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078245-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078245-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals, Inc. | ee1eaaf6-050b-48af-942b-5e3451edc164 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 68180-215 68180-217 68180-216 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 6eab1c0a-9328-42a6-8eae-d4e105c54716 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 0a34f28c-20e6-4f34-9c4a-70fb258aa300 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 8a3e5be8-0a4b-48a0-817f-6e3c7674109d | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 50090-4993 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | b4f5dd93-5f44-4c8c-9e3b-89ab1fa5a7fd | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct_Rx | 8de04bf2-83dd-c494-e053-2a95a90abade | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 078245 ANDA078245 72189-167 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4993 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4993 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-5113 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-5113 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-5113 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-5141 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-5141 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 57297-215 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 57297-216 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 57297-217 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 63629-6975 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-6975 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 68180-215 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-215 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-215 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-215 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-215 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-216 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-216 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-216 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-216 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-216 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-217 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-217 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-217 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-217 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-217 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7758 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7758 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7758 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9461 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2564 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2564 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2564 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2578 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2578 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 70518-2578 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 72189-167 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct_Rx | ANDA | Current |
| 72189-167 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct_Rx | ANDA | Current |
| 72189-167 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct_Rx | ANDA | Current |
| 72189-167 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct_Rx | ANDA | Current |