Application 200290
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A200290-001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | ||
| A200290-002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | ||
| A200290-003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 |
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 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | 2013-08-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | 2013-08-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | 2013-08-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2013-08-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2013-08-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2013-08-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2013-08-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2013-08-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2013-08-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2013-08-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2013-08-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2013-08-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2013-08-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2013-08-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2013-08-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2013-08-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200290-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2013-08-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200290-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2013-08-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200290-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2013-08-30 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200290-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200290-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200290-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200290-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200290-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200290-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200290-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200290-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200290-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200290-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200290-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200290-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200290-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200290-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200290-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200290-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200290-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200290-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200290-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200290-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200290-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200290-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A200290-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A200290-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200290-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200290-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200290-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A200290-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A200290-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A200290-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A200290-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A200290-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A200290-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A200290-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A200290-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A200290-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A200290-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A200290-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A200290-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A200290-001 | AB | 1 | 782e0a99824c… |
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 | St. Mary's Medical Park Pharmacy | aaf943ff-d6af-8ce2-e053-2995a90a7b76 | 2026-06-07 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Cardinal Health 107, LLC | b83d896a-c7e9-4508-814c-425b88a87b16 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 0f3a6984-e601-4a74-9910-49ee5e352d6b | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Coupler LLC | 53456224-db79-e7c1-e063-6394a90a90d5 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | c4b81f90-bcd0-45d0-99ce-35ca998d473a | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losortan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 25651749-8950-43ff-bcbd-3bb85f57a360 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals, Inc. | fe1df76d-4925-444d-8e30-9dd07f205fb7 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | PD-Rx Pharmaceuticals, Inc. | f9a92771-5c73-4f17-ac38-29fabfd4a919 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 5f7612dc-dccf-49e2-b541-3dab9dc1f97a | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | PD-Rx Pharmaceuticals, Inc. | abb56236-f2fe-45b5-93ac-35fd661f8992 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losortan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 1b285c10-f468-4d87-b36d-79047f686c58 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | 23117ad8-39ad-44f2-b7d2-2dbc8edc9734 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | d7b61f05-871d-4ffd-ab9b-9a3e60fd34c4 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 05818573-0b40-4731-a9d1-152c708905bf | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | Losartan potassium LOSARTAN POTASSIUM |
| LOSARTAN POTASSIUM 25 mg | LOSARTAN POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 4d60e755-40a6-4187-b09e-e55c735945aa | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | ba76eb91-bea6-4e37-e053-2a95a90a065a | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| LOSARTAN POTASSIUM 25 mg | LOSARTAN POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 372ba4ad-26ca-4675-8475-4b664fbecba9 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | 3ee3240f-78a1-4fd2-a779-c22693711721 | 2026-02-14 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | f29cc61a-afba-4ecb-8043-5f103872f1ae | 2026-02-14 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium LOSARTAN POTASSIUM |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | 2c810cde-fa40-4772-806e-c31809e6bbfb | 2026-02-11 | 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.