Application 076580
- Type
- ANDA
- Sponsor
- RANBAXY LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | TABLET;ORAL | 10MG | No | No |
| 002 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | TABLET;ORAL | 20MG | No | No |
| 003 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076580-001 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | ||
| A076580-002 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | ||
| A076580-003 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 |
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 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076580-002 | FOSINOPRIL SODIUM | 20MG | TABLET / ORAL | 2004-04-23 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076580-003 | FOSINOPRIL SODIUM | 40MG | TABLET / ORAL | 2004-04-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076580-001 | FOSINOPRIL SODIUM | 10MG | TABLET / ORAL | 2004-04-23 | 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 |
|---|---|---|---|---|---|---|
| Fosinopril Sodium | FOSINOPRIL SODIUM | Chartwell RX, LLC | ff1323cc-7ad8-488d-94a7-a11555db78a7 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium FOSINOPRIL SODIUM |
| Fosinopril Sodium | FOSINOPRIL SODIUM | Aurobindo Pharma Limited | aee04f17-8ee9-42f5-861f-b6ba17220ca4 | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium FOSINOPRIL SODIUM |
| Fosinopril Sodium | FOSINOPRIL | Bryant Ranch Prepack | fc38f1bb-f175-4a81-8ed9-c8701efdea35 | 2023-11-27 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium |
| Fosinopril sodium | FOSINOPIRL SODIUM | Bryant Ranch Prepack | 3d521d4d-29f8-40d7-971b-0efb68dfbff2 | 2023-11-27 | Boxed warning, Warnings, Adverse reactions | Fosinopril sodium |
| Fosinopril Sodium | FOSINOPRIL | Bryant Ranch Prepack | 6562a532-b502-4515-88df-591d71293b56 | 2023-10-19 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium |
| Fosinopril sodium | FOSINOPRIL SODIUM | A-S Medication Solutions | 46e3e4e8-c611-4d4f-ad57-050b4c01fcd8 | 2023-09-25 | Boxed warning, Warnings, Adverse reactions | Fosinopril sodium FOSINOPRIL SODIUM |
| Fosinopril sodium | FOSINOPRIL SODIUM | Bryant Ranch Prepack | ee78de8e-22f4-4c3b-a721-e9464d704eda | 2023-05-11 | Boxed warning, Warnings, Adverse reactions | Fosinopril sodium FOSINOPRIL SODIUM |
| Fosinopril sodium | FOSINOPRIL SODIUM | Exelan Pharmaceuticals, Inc. | e2ff3171-a17a-456a-9272-ca1682b01d19 | 2023-03-23 | Boxed warning, Warnings, Adverse reactions | Fosinopril sodium FOSINOPRIL SODIUM |
| Fosinopril Sodium | FOSINOPRIL | A-S Medication Solutions | 880e5bf4-ced8-4765-a5c2-2361fd06ed9c | 2023-02-17 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium |
| Fosinopril Sodium | FOSINOPRIL | Cipla USA Inc. | 736fe52f-69fb-48b2-b1c5-f06531878538 | 2023-01-20 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium |
| Fosinopril sodium | FOSINOPIRL SODIUM | Solco Healthcare LLC | 0a66f606-5e6f-473d-8a1e-9ef316adb2e2 | 2021-10-25 | Boxed warning, Warnings, Adverse reactions | Fosinopril sodium FOSINOPRIL SODIUM |