Application 078010
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
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 |
| 003 | FUROSEMIDE | FUROSEMIDE | TABLET;ORAL | 80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078010-001 | FUROSEMIDE | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | |
| A078010-002 | FUROSEMIDE | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | |
| A078010-003 | FUROSEMIDE | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078010-001 | AB |
| A078010-002 | AB |
| A078010-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078010-002 | FUROSEMIDE | 40MG | TABLET / ORAL | AB | 2006-09-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078010-003 | FUROSEMIDE | 80MG | TABLET / ORAL | AB | 2006-09-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078010-001 | FUROSEMIDE | 20MG | TABLET / ORAL | AB | 2006-09-18 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078010-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078010-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078010-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078010-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078010-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078010-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078010-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078010-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078010-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078010-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078010-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078010-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078010-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078010-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078010-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078010-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078010-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078010-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078010-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078010-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078010-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078010-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078010-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078010-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078010-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078010-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078010-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078010-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078010-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078010-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078010-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078010-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078010-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078010-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078010-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078010-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078010-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078010-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078010-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078010-001 | AB | 1 | 8072bd15b7f6… |
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 | REMEDYREPACK INC. | e8c27f1c-dc81-44b1-8663-a7d663bad89f | 2026-06-23 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | Coupler LLC | 4cc2c2d1-2fa4-f6b6-e063-6294a90a290e | 2026-03-11 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | A-S Medication Solutions | ac64c926-88e9-453a-884c-72ec6a1c746a | 2025-10-15 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | A-S Medication Solutions | 3f3248cd-d62f-49ca-8788-f059e8facd91 | 2025-10-15 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | A-S Medication Solutions | c81d313c-65a3-4fb5-b6cd-b1c1ec7dca03 | 2025-10-15 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | A-S Medication Solutions | 5d7eb469-2371-4abb-8f49-be1596f10f27 | 2025-10-15 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | A-S Medication Solutions | 85375079-a9f1-42d4-8e15-c1d31395b29d | 2025-10-15 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | Coupler LLC | 3eed4bbf-7d0e-e852-e063-6394a90a85c2 | 2025-09-16 | Warnings, Adverse reactions | 078010 ANDA078010 |
| Furosemide | FUROSEMIDE | Ipca Laboratories Limited | 0acd293b-ecab-4879-a8e7-cd1b76148f2a | 2025-01-20 | Warnings, Adverse reactions | 078010 ANDA078010 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-131 | Furosemide | Furosemide | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-584 | Furosemide | Furosemide | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-490 | Furosemide | Furosemide | Rebel Distirbutors Corp | ANDA | Current |
| 21695-491 | Furosemide | Furosemide | Rebel Distirbutors Corp | ANDA | Current |
| 33261-174 | Furosemide | Furosemide | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-374 | Furosemide | Furosemide | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 45861-107 | Active-Medicated specimen collection kit | Urine specimen collection kit | Pharmaceutica North America, Inc | ANDA | Current |
| 50436-3840 | Furosemide | Furosemide | Unit Dose Services | ANDA | Current |
| 50436-3841 | Furosemide | Furosemide | Unit Dose Services | ANDA | Current |
| 53808-0671 | Furosemide | Furosemide | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0998 | Furosemide | FUROSEMIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 58517-400 | Furosemide | Furosemide | New Horizon Rx Group, LLC | ANDA | Current |
| 60760-624 | FUROSEMIDE | FUROSEMIDE | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-625 | FUROSEMIDE | FUROSEMIDE | St Marys Medical Park Pharmacy | ANDA | Current |
| 63187-097 | Furosemide | Furosemide | Proficient Rx LP | ANDA | Current |
| 63187-097 | Furosemide | Furosemide | Proficient Rx LP | ANDA | Current |
| 63187-437 | Furosemide | Furosemide | Proficient Rx LP | ANDA | Current |
| 63187-437 | Furosemide | Furosemide | Proficient Rx LP | ANDA | Current |
| 63304-624 | Furosemide | Furosemide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-625 | Furosemide | Furosemide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-626 | Furosemide | Furosemide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63629-1434 | Furosemide | Furosemide | Bryant Ranch Prepack | ANDA | Current |
| 63739-541 | Furosemide | Furosemide | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-541 | Furosemide | Furosemide | McKesson Packaging Services a business unit of McKesson Corporation | ANDA | Current |
| 63739-542 | Furosemide | Furosemide | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-542 | Furosemide | Furosemide | McKesson Packaging Services a business unit of McKesson Corporation | ANDA | Current |
| 63739-543 | Furosemide | Furosemide | McKesson Packaging Services a business unit of McKesson Corporation | ANDA | Current |
| 64725-0624 | Furosemide | Furosemide | TYA Pharmaceuticals | ANDA | Current |
| 64725-0625 | Furosemide | Furosemide | TYA Pharmaceuticals | ANDA | Current |
| 66116-375 | Furosemide | Furosemide | MedVantx, Inc. | ANDA | Current |
| 67046-228 | Furosemide | Furosemide | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0650 | Furosemide | Furosemide | RedPharm Drug Inc. | ANDA | Current |
| 68788-9226 | Furosemide | Furosemide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9778 | Furosemide | Furosemide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69677-030 | Rx-Specimen Collection Kit | specimen collection kit | MAS Management Group Inc. | ANDA | Current |