Application 203835
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
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 |
|---|---|---|---|---|---|---|---|
| A203835-001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | |
| A203835-002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | |
| A203835-003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203835-001 | AB |
| A203835-002 | AB |
| A203835-003 | 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 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203835-002 | LOSARTAN POTASSIUM | 50MG | TABLET / ORAL | AB | 2015-08-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203835-003 | LOSARTAN POTASSIUM | 100MG | TABLET / ORAL | AB | 2015-08-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203835-001 | LOSARTAN POTASSIUM | 25MG | TABLET / ORAL | AB | 2015-08-12 | 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 | A203835-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203835-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203835-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203835-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203835-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203835-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203835-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203835-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203835-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203835-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203835-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203835-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203835-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203835-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203835-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203835-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203835-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203835-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203835-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203835-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203835-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203835-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203835-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203835-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203835-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203835-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203835-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203835-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203835-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203835-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203835-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203835-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203835-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203835-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203835-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203835-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203835-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203835-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203835-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203835-001 | 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 | A-S Medication Solutions | 67ffab1a-9e80-48dd-a6c6-1b586161fe50 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | d1000341-9f81-403f-a8e4-55e1eead432a | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | 54e902e6-d443-484a-bed1-e2669656b513 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 50090-4645 |
| Losartan Potassium | LOSARTAN POTASSIUM | NorthStar RxLLC | 394398e1-119e-4943-b414-27261f5d4842 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| Losartan Potassium | LOSARTAN POTASSIUM | Camber Pharmaceuticals, Inc. | cafd54e8-42a8-474c-8ea8-49ec74c2b0d3 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 31722-700 31722-702 31722-701 |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | 27e783ce-3353-448a-b0a3-c954dfd2e4c7 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 50090-4712 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | adc984d5-91d6-ef17-e053-2a95a90a7571 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-5175 |
| Losartan Potassium | LOSARTAN POTASSIUM | DirectRx | d358499d-5ebb-75b2-e053-2a95a90a4223 | 2025-01-20 | Warnings, Adverse reactions | 203835 ANDA203835 |
| Losartan Potassium | LOSARTAN POTASSIUM | Direct_Rx | e9aa536e-0747-45bf-e053-2995a90ae7d6 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | DIRECT RX | a5b5da65-a4d5-1bd5-e053-2a95a90a6a60 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| Losartan Potassium | LOSARTAN POTASSIUM | A-S Medication Solutions | f68fd1a2-1cbf-47c8-b8c4-df49cf17540e | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 50090-4914 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | aa58c629-f7d9-a6e0-e053-2995a90ac188 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-2216 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | 9c0809dc-cbdd-1a33-e053-2995a90a4825 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-5147 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | 9f1c20aa-2028-412d-e053-2995a90a1368 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-5181 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | a11075f1-f7d0-0c3d-e053-2995a90a0c9d | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-5209 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | a1123700-f4c7-2b62-e053-2a95a90a87d6 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-5212 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | 97a50b38-f5b3-0a96-e053-2995a90a345f | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-5114 |
| Losartan Potassium | LOSARTAN POTASSIUM | NuCare Pharmaceuticals,Inc. | 6eec2a4c-6b5c-11a5-e053-2991aa0aa56b | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 68071-4471 |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | XLCare Pharmaceuticals, Inc. | 20421665-0401-4f6e-9e1d-232c654efb0f | 2023-01-17 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | Aphena Pharma Solutions - Tennessee, LLC | 8015c22c-d944-4a49-8721-70d0c1b98526 | 2022-10-18 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
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 |
|---|---|---|---|---|---|
| 31722-700 | Losartan Potassium | Losartan Potassium | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-700 | Losartan Potassium | Losartan Potassium | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-701 | Losartan Potassium | Losartan Potassium | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-701 | Losartan Potassium | Losartan Potassium | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-702 | Losartan Potassium | Losartan Potassium | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-702 | Losartan Potassium | Losartan Potassium | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 42708-113 | Losartan Potassium | Losartan Potassium | QPharma Inc | ANDA | Current |
| 42708-113 | Losartan Potassium | Losartan Potassium | QPharma Inc | ANDA | Current |
| 42708-151 | Losartan Potassium | Losartan Potassium | QPharma Inc | ANDA | Current |
| 42708-152 | Losartan Potassium | Losartan Potassium | QPharma Inc | ANDA | Current |
| 43063-854 | Losartan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-854 | Losartan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-854 | Losartan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-854 | Losartan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-854 | Losartan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-854 | Losartan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-4489 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4489 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4489 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4645 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4645 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4645 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4712 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4712 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4712 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4910 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-4914 | Losartan Potassium | Losartan Potassium | A-S Medication Solutions | ANDA | Current |
| 51655-828 | Losartan Potassium | Losartan Potassium | Northwind Pharmaceuticals | ANDA | Current |
| 53002-3638 | Losartan Potassium | Losartan Potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-4624 | Losartan Potassium | Losartan Potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-4643 | Losartan Potassium | Losartan Potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 60760-786 | Losartan Potassium | Losartan Potassium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-296 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-296 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-296 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-357 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-357 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-708 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-708 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-708 | Losartan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 68071-2216 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2216 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2344 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4471 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4471 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4471 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5114 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5114 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5147 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5147 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5175 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5175 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5181 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5181 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5209 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5209 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5212 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5212 | Losartan Potassium | Losartan Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68645-577 | Losartan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-578 | Losartan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-579 | Losartan Potassium | Losartan Potassium | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-6405 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7664 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7664 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7664 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7665 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7665 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7665 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7737 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7737 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7737 | Losartan Potassium | Losartan Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2786 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2786 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2786 | Losartan Potassium | Losartan Potassium | REMEDYREPACK INC. | ANDA | Current |
| 70934-616 | Losartan Potassium | Losartan Potassium | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-627 | Losartan Potassium | Losartan Potassium | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-657 | Losartan Potassium | Losartan Potassium | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-1102 | Losartan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1102 | Losartan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1580 | Losartan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32472 | ORIG | 2015-08-14 |