Application 091629
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091629-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | |
| A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | |
| A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091629-001 | AB |
| A091629-002 | AB |
| A091629-003 | 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 | A091629-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091629-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091629-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091629-001 | 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 | A091629-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091629-003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | RS | 2010-01-06 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091629-001 | 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 | A091629-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091629-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091629-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091629-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091629-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091629-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091629-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091629-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091629-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091629-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091629-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091629-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091629-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091629-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091629-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091629-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091629-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091629-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091629-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091629-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091629-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091629-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091629-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091629-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091629-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091629-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091629-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091629-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091629-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091629-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091629-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091629-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091629-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091629-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091629-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091629-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091629-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091629-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091629-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091629-001 | 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 | REMEDYREPACK INC. | 9f9cd7a7-be95-4ea8-8247-eb7ecbd36936 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | be99cc03-ea65-4b17-bd9e-df7ae4307778 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | dc9512cf-db66-40e9-afcb-1d6a722772e8 | 2026-02-14 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 50090-1745 50090-1641 50090-2632 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 5ec290f4-bf21-4c5b-a576-8eb2bd6bd379 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 50090-4447 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Coupler LLC | 44fd38d2-cb8b-d0e8-e063-6294a90a994e | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | bc8b9ae2-8263-4624-8629-4f856392f9da | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| 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 | 091629 ANDA091629 43063-986 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 60f3f17d-fd28-406d-97ca-9f01f5f1c72c | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | NorthStar Rx LLC | 25318baf-9c2f-458f-b9ea-f52dabca49af | 2025-09-06 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 16714-225 16714-224 16714-226 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | dc177d6c-c754-4379-8c2f-1cf6f52f950a | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 24ee299f-4466-45d4-9013-17791e1998bb | 2025-08-04 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | DirectRx | cf4278a3-fbb7-a8ab-e053-2a95a90abc0f | 2025-01-20 | Warnings, Adverse reactions | 091629 ANDA091629 |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct_Rx | 8de04bf2-83dd-c494-e053-2a95a90abade | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 98b97680-474c-4e70-89dd-15bb49773125 | 2024-08-21 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | a6e7d8a7-f969-4a21-ac28-93c77ed1fa63 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 63187-727 |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 198d5151-7982-4639-9fe1-6573a4529348 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 091629 ANDA091629 63187-599 63187-602 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-224 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-224 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-224 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-224 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-224 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-225 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-225 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-225 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-225 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-225 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-226 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-226 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-226 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-226 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 16714-226 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | NorthStar Rx LLC | ANDA | Current |
| 43063-873 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-873 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-873 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-873 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-986 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-986 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-986 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-986 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-986 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-986 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1641 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1641 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1745 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1745 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1745 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1745 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1745 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2632 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4301 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4305 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4305 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4447 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4447 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 52343-116 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-116 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-117 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-117 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-118 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-118 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | ACETRIS HEALTH, LLC | ANDA | Current |
| 57237-207 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-207 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-207 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-207 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-207 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-208 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-208 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-208 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-208 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-208 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-209 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-209 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-209 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-209 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 57237-209 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Rising Health, LLC | ANDA | Current |
| 60760-472 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | St. Marys Medical Park Pharmacy | ANDA | Current |
| 61919-732 | Losartan Potassium HCTZ | Losartan Potassium HCTZ | DIRECT RX | ANDA | Current |
| 61919-732 | Losartan Potassium HCTZ | Losartan Potassium HCTZ | DIRECT RX | ANDA | Current |
| 61919-797 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | DIRECT RX | ANDA | Current |
| 61919-797 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | DIRECT RX | ANDA | Current |
| 61919-797 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | DIRECT RX | ANDA | Current |
| 61919-873 | LOSARTAN POT/HCTZ | LOSARTAN POT/HCTZ | Direct_Rx | ANDA | Current |
| 61919-873 | LOSARTAN POT/HCTZ | LOSARTAN POT/HCTZ | Direct_Rx | ANDA | Current |
| 63187-599 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63187-599 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63187-602 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63187-602 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63187-727 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63187-727 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63629-6845 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-6845 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8089 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8089 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8089 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63739-527 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-527 | Losartan Potassium and Hydrochlorothiazide | Losartan Potassium and Hydrochlorothiazide | McKesson Corporation | ANDA | Current |