Application 091652
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | ||
| A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | ||
| A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET / ORAL | 2010-10-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091652-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | 2010-04-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091652-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2010-10-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091652-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | 2010-10-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A091652-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091652-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091652-003 | AB | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A091652-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A091652-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A091652-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091652-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A091652-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A091652-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091652-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A091652-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A091652-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091652-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A091652-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A091652-003 | AB | 1 | ea99ee380514… |
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 | Jubilant Cadista Pharmaceuticals Inc. | e0b74a86-3d36-1af0-e538-41b45b8d2cc3 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | f5f462c6-0604-49d3-af8f-fecbde23be99 | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | Losartan potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Solco Healthcare US, LLC | 6d677f9e-c0e4-4d6e-bea2-a58e986e4635 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| losartan potassium and hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 68a99bb3-69ad-42e2-9d50-390f75744671 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | losartan potassium and hydrochlorothiazide |
| 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 | Losartan Potassium and Hydrochlorothiazide |
| 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 | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | dcb39c6b-430d-4b3d-ba6f-5bf1efe116aa | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Limited | bbf7e20d-dfc2-4115-8788-c0cac15a1148 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 60f3f17d-fd28-406d-97ca-9f01f5f1c72c | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | NorthStar Rx LLC | 25318baf-9c2f-458f-b9ea-f52dabca49af | 2025-09-06 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 0e015b9a-0ac1-4ec3-bbe7-7a672d30e1f4 | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 8d56b5db-e72d-4f09-aed4-09e65a27e9ff | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | be81ba65-c434-4287-97d3-cd11d6031636 | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | AvKARE | e78b2195-a2da-3d03-e053-2a95a90a7d56 | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | 473d90ed-e262-4ec6-975b-494d89f1ad70 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| losartan potassium and hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | f9cfb39e-4367-40a0-86ee-138645aace56 | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | losartan potassium and hydrochlorothiazide |
| losartan potassium and hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 3c873a8c-b21e-448e-87f3-333419739cdd | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | losartan potassium and hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | dc177d6c-c754-4379-8c2f-1cf6f52f950a | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 46cf633d-70a5-4d3b-b349-ad74c23ddace | 2025-08-04 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 24ee299f-4466-45d4-9013-17791e1998bb | 2025-08-04 | 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.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9350 | ORIG | 2010-04-09 |