Application 078243
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
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 |
|---|---|---|---|---|---|---|---|
| A078243-001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | |
| A078243-002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | |
| A078243-003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078243-001 | AB |
| A078243-002 | AB |
| A078243-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078243-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078243-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078243-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078243-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078243-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078243-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078243-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078243-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078243-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078243-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078243-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078243-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078243-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078243-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078243-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078243-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078243-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078243-001 | AB | 1 | 301d65b070ca… |
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 | Cardinal Health 107, LLC | 021cd76a-b093-4704-8410-5e7d01e20a54 | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | Major Pharmaceuticals | c15387df-87a4-4784-acb5-7dd550498f8f | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losartan Potassium | LOSARTAN POTASSIUM | Zydus Pharmaceuticals USA Inc. | 3233c707-70b6-4c29-8210-913eeb2a38ed | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 68382-137 68382-135 68382-136 |
| Losartan Potassium | LOSARTAN POTASSIUM | American Health Packaging | e7f6b25b-ec4c-4c3a-a541-617d2d9ab393 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 68084-348 68084-347 68084-346 |
| Losartan Potassium | LOSARTAN POTASSIUM | Cardinal Health 107, LLC | b83d896a-c7e9-4508-814c-425b88a87b16 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losortan Potassium | LOSARTAN POTASSIUM | Preferred Pharmaceuticals Inc. | 25651749-8950-43ff-bcbd-3bb85f57a360 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| Losortan Potassium | LOSARTAN POTASSIUM | Bryant Ranch Prepack | 1b285c10-f468-4d87-b36d-79047f686c58 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 71335-1644 |
| Losartan Potassium | LOSARTAN POTASSIUM | Zydus Lifesciences Limited | 9ccd6823-e813-472c-99cd-c6ef25e74bed | 2026-01-12 | 078243 ANDA078243 65841-731 65841-730 65841-729 | |
| Losartan Potassium | LOSARTAN POTASSIUM | Quallent Pharmaceuticals Health LLC | 1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 82009-042 82009-044 82009-043 |
| Losortan Potassium | LOSARTAN POTASSIUM | AvPAK | a6cd0b5f-2bd6-bed9-e053-2995a90a3191 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | a58c56b2-e05c-6697-e053-2a95a90ad466 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 72189-082 |
| Losortan Potassium | LOSARTAN POTASSIUM | Proficient Rx LP | 364fe10e-11ca-4ee6-9f67-c85dec09aca5 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 078243 ANDA078243 |
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 |
|---|---|---|---|---|---|
| 63739-686 | Losortan Potassium | Losartan Potassium | McKesson Corporation | ANDA | Current |
| 63739-686 | Losartan Potassium | Losartan Potassium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-686 | Losartan Potassium | Losartan Potassium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-698 | Losartan Potassium | Losartan Potassium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-698 | Losartan Potassium | Losartan Potassium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-698 | Losartan Potassium | Losartan Potassium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-698 | Losartan Potassium | Losartan Potassium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-698 | Losartan Potassium | Losartan Potassium | McKesson Corporation | ANDA | Current |
| 65841-729 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-729 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-729 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-729 | Losartan Potassium | Losartan Potassium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-730 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-730 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-730 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-730 | Losartan Potassium | Losartan Potassium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-731 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-731 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-731 | Losartan Potassium | Losartan Potassium | Cadila Healthcare Limited | ANDA | Current |
| 65841-731 | Losartan Potassium | Losartan Potassium | Zydus Lifesciences Limited | ANDA | Current |
| 68071-3182 | Losortan Potassium | Losartan Potassium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3209 | Losortan Potassium | Losartan Potassium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68084-346 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-346 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-346 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-347 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-347 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-347 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-348 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-348 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68084-348 | Losartan Potassium | Losartan Potassium | American Health Packaging | ANDA | Current |
| 68382-135 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-135 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-135 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-136 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-136 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-136 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-137 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-137 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-137 | Losortan Potassium | Losartan Potassium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68645-586 | Losortan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-586 | Losortan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-586 | Losortan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-6445 | Losortan Potassium | Losartan Potassium | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-7736 | Losortan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7736 | Losortan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0557 | Losortan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0557 | Losortan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1319 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1319 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1319 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1319 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70934-942 | Losortan Potassium | Losartan Potassium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-1644 | Losortan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1644 | Losortan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
| 72189-082 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | ANDA | Current |
| 72189-082 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | ANDA | Current |
| 82009-042 | Losortan Potassium | Losartan Potassium | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-042 | Losartan Potassium | Losartan Potassium | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-043 | Losortan Potassium | Losartan Potassium | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-043 | Losartan Potassium | Losartan Potassium | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-044 | Losortan Potassium | Losartan Potassium | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-044 | Losartan Potassium | Losartan Potassium | Quallent Pharmaceuticals Health LLC | ANDA | Current |