Application 076958
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | TABLET;ORAL | 25MG | No | No |
| 002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | TABLET;ORAL | 50MG | No | No |
| 003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076958-001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | ||
| A076958-002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | ||
| A076958-003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 |
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 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076958-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2010-04-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076958-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2010-04-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076958-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2010-04-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A076958-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076958-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076958-003 | 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 | LOSARTAN POTASSIUM | Solco Healthcare US, LLC | fa0cf2c2-6238-4edd-94e2-b670b98a0da4 | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 94eb89aa-296f-4e8f-a077-30a1be01ad52 | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 68ed9727-987e-4bb6-98b4-b98150bb6404 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan potassium | LOSARTAN POTASSIUM | Macleods Pharmaceuticals Limited | 85d69d02-c5ef-467e-94aa-903100218795 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | Losartan potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN | Granules India Ltd | f9953f51-f30a-952d-e053-6394a90abf5f | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium |
| Losartan Potassium | LOSARTAN POTASSIUM | Alembic Pharmaceuticals Inc. | 1dadbe02-289c-4312-9e65-40f3314dcc31 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 35856cd6-3fc7-2c03-e063-6294a90a2f69 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 3585b1d3-ccb7-747e-e063-6294a90a4b77 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 3585fdcc-d22a-b0a6-e063-6294a90a9b0c | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals.Inc. | 351d3c5c-05c6-921a-e063-6394a90abef9 | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | 27e783ce-3353-448a-b0a3-c954dfd2e4c7 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | adc984d5-91d6-ef17-e053-2a95a90a7571 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan potassium | LOSARTAN POTASSIUM | Coupler LLC | 2d5524d5-c76b-44af-e063-6294a90a2ef1 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | Losartan potassium LOSARTAN POTASSIUM |
| Losartan potassium | LOSARTAN POTASSIUM | Coupler LLC | 2d1b1648-8b24-cf4f-e063-6294a90afdd8 | 2025-02-01 | Boxed warning, Warnings, Adverse reactions | Losartan potassium LOSARTAN POTASSIUM |
| Losartan potassium Tablets, 100 mg | LOSARTAN POTASSIUM | Coupler LLC | 2d1b03bb-2355-baac-e063-6294a90a9b40 | 2025-02-01 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | DirectRx | d358499d-5ebb-75b2-e053-2a95a90a4223 | 2025-01-20 | Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Direct_Rx | e9aa536e-0747-45bf-e053-2995a90ae7d6 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | a5b5da65-a4d5-1bd5-e053-2a95a90a6a60 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM LOSARTAN POTASSIUM |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | a58c56b2-e05c-6697-e053-2a95a90ad466 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | de5c0c87-e90b-fc14-e053-2a95a90af0c5 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7364 | Losartan Potassium | Losartan Potassium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7365 | Losartan Potassium | Losartan Potassium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7366 | Losartan Potassium | Losartan Potassium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0179-0200 | Losartan Potassium | Losartan Potassium | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0202 | Losartan Potassium | Losartan Potassium | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0203 | Losartan Potassium | Losartan Potassium | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0615-7604 | Losartan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7605 | Losartan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7606 | Losartan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 42708-035 | Losartan Potassium | Losartan Potassium | QPharma Inc | ANDA | Current |
| 42708-035 | Losartan Potassium | Losartan Potassium | QPharma Inc | ANDA | Current |
| 43063-766 | Losartan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1624 | Losartan Potassium | Losartan Potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1624 | Losartan Potassium | Losartan Potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 60429-863 | Losartan Potassium | Losartan Potassium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-863 | Losartan Potassium | Losartan Potassium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-863 | Losartan Potassium | Losartan Potassium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-864 | Losartan Potassium | Losartan Potassium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-864 | Losartan Potassium | Losartan Potassium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-865 | Losartan Potassium | Losartan Potassium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-865 | Losartan Potassium | Losartan Potassium | Golden State Medical Supply, Inc. | ANDA | Current |
| 63187-589 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-935 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-935 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63629-6381 | Losartan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
| 66116-452 | Losartan Potassium | Losartan Potassium | MedVantx, Inc. | ANDA | Current |
| 66336-665 | Losartan Potassium | Losartan Potassium | Dispensing Solutions, Inc. | ANDA | Current |
| 66336-666 | Losartan Potassium | Losartan Potassium | Dispensing Solutions, Inc. | ANDA | Current |
| 68071-1989 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3003 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3139 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4000 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-0183 | Losartan Potassium | Losartan Potassium | Carilion Materials Management | ANDA | Current |
| 68645-407 | Losartan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-409 | Losartan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-411 | Losartan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-7365 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0083 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0626 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0626 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0760 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0760 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 71610-009 | Losartan Potassium | Losartan Potassium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-009 | Losartan Potassium | Losartan Potassium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-065 | Losartan Potassium | Losartan Potassium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31178 | ORIG | 2010-04-16 |