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 | Proficient Rx LP | 5b1f6677-9473-467f-9fb6-efadbd8828e8 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 63187-708 |
| Losartan Potassium | LOSARTAN POTASSIUM | Proficient Rx LP | aeb4ce44-ab34-4f0e-a674-de42d404d104 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 63187-296 |
| Losartan Potassium | LOSARTAN POTASSIUM | Proficient Rx LP | 435c5544-491b-476a-b950-712b2c18e334 | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 63187-357 |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | Aphena Pharma Solutions - Tennessee, LLC | 2f738295-53d6-4d4f-8864-9faf893dbdf2 | 2020-10-07 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| Losartan Potassium | LOSARTAN POTASSIUM | Aphena Pharma Solutions - Tennessee, LLC | be2432ba-2118-418a-addf-56db9b6c39d2 | 2020-10-07 | Boxed warning, Warnings, Adverse reactions | 203835 ANDA203835 |
| Losartan Potassium | LOSARTAN POTASSIUM | Aphena Pharma Solutions - Tennessee, LLC | 3bcbcb6c-ee8d-44b1-9c78-92712291e891 | 2018-10-15 | 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 |