Application 018487
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FUROSEMIDE | FUROSEMIDE | TABLET;ORAL | 20MG | No | No |
| 002 | FUROSEMIDE | FUROSEMIDE | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018487-001 | FUROSEMIDE | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | ||
| N018487-002 | FUROSEMIDE | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 |
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 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018487-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018487-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | Approved before 1982 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018487-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018487-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018487-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018487-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018487-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018487-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018487-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018487-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018487-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N018487-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018487-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018487-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018487-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N018487-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018487-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N018487-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018487-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N018487-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018487-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N018487-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018487-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N018487-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018487-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018487-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018487-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N018487-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018487-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N018487-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018487-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N018487-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018487-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N018487-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018487-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N018487-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018487-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N018487-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018487-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018487-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N018487-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N018487-002 | AB | 1 | 1c564ffb4f44… |
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 |
|---|---|---|---|---|---|---|
| Furosemide | FUROSEMIDE | Leading Pharma, LLC | b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe | 2022-11-11 | Warnings, Adverse reactions | Furosemide FUROSEMIDE |
| Furosemide | FUROSEMIDE | Precision Dose Inc. | 4a746634-379b-4847-a965-7607d2a71bed | 2022-09-21 | Warnings, Adverse reactions | Furosemide FUROSEMIDE |
| Furosemide | FUROSEMIDE | Aphena Pharma Solutions - Tennessee, LLC | 6f124d7d-a19d-4de6-8ea4-719a42eb520b | 2022-03-10 | Warnings, Adverse reactions | Furosemide FUROSEMIDE |
| FUROSEMIDE | FUROSEMIDE | HF Acquisition Co LLC, DBA HealthFirst | c5d9b063-e3fe-ec2f-e053-2995a90ab3f2 | 2021-06-28 | Warnings, Adverse reactions | FUROSEMIDE FUROSEMIDE |
| Furosemide | FUROSEMIDE | Proficient Rx LP | ce84359c-2f76-421a-9b2b-79b1c2be2f20 | 2021-01-01 | Warnings, Adverse reactions | Furosemide FUROSEMIDE |
| Furosemide | FUROSEMIDE | Gland Pharma Limited | 644704c0-e6a5-4804-bfa6-795c8f83aa7a | 2020-07-03 | Boxed warning, Warnings, Adverse reactions | Furosemide FUROSEMIDE |
| Furosemide | FUROSEMIDE | Aphena Pharma Solutions - Tennessee, LLC | 1d2733ac-6fa6-44d1-96d4-f1a698045ad2 | 2018-04-18 | Warnings, Adverse reactions | Furosemide FUROSEMIDE |
| Furosemide | FUROSEMIDE | Aphena Pharma Solutions - Tennessee, LLC | 6fbf7f3d-7566-44d5-9507-c4460238fc91 | 2018-02-09 | Warnings, Adverse reactions | Furosemide FUROSEMIDE |
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 |
|---|---|---|---|---|---|
| 0378-0208 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0208 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0208 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0208 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0216 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0216 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0216 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0216 | Furosemide | furosemide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 43063-806 | Furosemide | furosemide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-806 | Furosemide | furosemide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-806 | Furosemide | furosemide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-806 | Furosemide | furosemide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43353-341 | Furosemide | furosemide | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 50090-2323 | Furosemide | furosemide | A-S Medication Solutions | NDA | Current |
| 50090-2560 | Furosemide | furosemide | A-S Medication Solutions | NDA | Current |
| 50090-2560 | Furosemide | furosemide | A-S Medication Solutions | NDA | Current |
| 51079-072 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 51079-072 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 51079-072 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 51079-072 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 51079-073 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 51079-073 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 51079-073 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 51079-073 | Furosemide | furosemide | Mylan Institutional Inc. | NDA | Current |
| 53808-0367 | Furosemide | FUROSEMIDE | State of Florida DOH Central Pharmacy | NDA | Current |
| 55154-5539 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 55154-5539 | Furosemide | furosemide | Cardinal Health 107, LLC | NDA | Current |
| 55154-5539 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 55154-5539 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 55154-5539 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 55154-5540 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 55154-5540 | Furosemide | furosemide | Cardinal Health 107, LLC | NDA | Current |
| 55154-5540 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 55154-5540 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 55154-5540 | Furosemide | furosemide | Cardinal Health | NDA | Current |
| 63629-8057 | Furosemide | furosemide | Bryant Ranch Prepack | NDA | Current |
| 67046-219 | Furosemide | furosemide | Contract Pharmacy Services-PA | NDA | Current |
| 67296-0691 | Furosemide | furosemide | RedPharm Drug, Inc. | NDA | Current |
| 67296-0691 | Furosemide | furosemide | RedPharm Drug, Inc. | NDA | Current |
| 68071-2325 | Furosemide | furosemide | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 70518-0120 | Furosemide | furosemide | REMEDYREPACK INC. | NDA | Current |
| 70518-0580 | Furosemide | furosemide | REMEDYREPACK INC. | NDA | Current |
| 70518-0580 | Furosemide | furosemide | REMEDYREPACK INC. | NDA | Current |
| 70518-1072 | Furosemide | furosemide | REMEDYREPACK INC. | NDA | Current |
| 70518-1072 | Furosemide | furosemide | REMEDYREPACK INC. | NDA | Current |
| 70518-1737 | Furosemide | furosemide | REMEDYREPACK INC. | NDA | Current |
| 70518-1737 | Furosemide | furosemide | REMEDYREPACK INC. | NDA | Current |
| 71335-0397 | Furosemide | furosemide | Bryant Ranch Prepack | NDA | Current |
| 71335-0397 | Furosemide | furosemide | Bryant Ranch Prepack | NDA | Current |
| 71335-0601 | Furosemide | furosemide | Bryant Ranch Prepack | NDA | Current |
| 71335-0601 | Furosemide | furosemide | Bryant Ranch Prepack | NDA | Current |
| 71335-1632 | Furosemide | furosemide | Bryant Ranch Prepack | NDA | Current |
| 71610-284 | Furosemide | furosemide | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |