Application 218015
- Type
- ANDA
- Sponsor
- GRANULES
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 |
|---|---|---|---|---|---|---|---|
| A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | ||
| A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | ||
| A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET / ORAL | 2023-09-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | d4dbc9d85df4… | ||
| 2026-11-14 07:37:17 | 2026-10 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | d4dbc9d85df4… | ||
| 2026-11-14 07:37:17 | 2026-10 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | d4dbc9d85df4… | ||
| 2026-10-15 13:18:30 | 2026-09 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218015-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2023-09-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218015-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2023-09-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218015-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2023-09-29 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A218015-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A218015-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A218015-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A218015-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A218015-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A218015-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A218015-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A218015-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A218015-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A218015-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A218015-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A218015-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A218015-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A218015-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A218015-003 | AB | 1 | 9b2671bbb829… |
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 | A-S Medication Solutions | c8740506-c679-4c41-a96a-8ddbcddd72c6 | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | c6ed6f74-0eca-4f99-8c7e-dd3f56167f01 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 6bd15e74-2ca2-49c8-8c01-0a647d3fa5df | 2024-01-18 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | a4aa7f77-c98d-4b70-84bb-e16a06fc7952 | 2023-12-04 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 88fabecc-6e53-464b-9659-12b2472c89ce | 2023-12-04 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 42942482-1f54-4c7f-9d5f-4aaf20abb3e3 | 2023-11-16 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 8d992a4c-8740-4636-928f-bb808eae3336 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| losartan potassium and hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 35099fd1-1bc9-428b-9b9c-71f574cc4156 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | losartan potassium and hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | a6e7d8a7-f969-4a21-ac28-93c77ed1fa63 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 6dd115b5-9268-4b66-bae8-0aa2605ebbd3 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 198d5151-7982-4639-9fe1-6573a4529348 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 7897d182-2859-4a40-af4d-aaa9d9720fd9 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 33710c3c-6f17-457a-8665-04c23bca8b75 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.