Application 020528
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MAVIK | TRANDOLAPRIL | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | MAVIK | TRANDOLAPRIL | TABLET;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | MAVIK | TRANDOLAPRIL | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020528-001 | MAVIK | TRANDOLAPRIL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | |
| N020528-002 | MAVIK | TRANDOLAPRIL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | |
| N020528-003 | MAVIK | TRANDOLAPRIL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 |
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| 2026-08 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020528-002 | MAVIK | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020528-003 | MAVIK | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020528-001 | MAVIK | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1996-04-26 | 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 |
|---|---|---|---|---|---|---|
| Trandolapril | TRANDOLAPRIL | Lupin Pharmaceuticals, Inc. | 8143a6cf-dadc-4ef7-a8db-d16d7150ad34 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | TRANDOLAPRIL |
| Trandolapril | TRANDOLAPRIL | Bryant Ranch Prepack | 514f53e6-ff6b-4d02-9db9-2575b15aa5f0 | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | TRANDOLAPRIL |
| Trandolapril | TRANDOLAPRIL | Bryant Ranch Prepack | 57f8aac6-3bd3-4ae1-aab2-759c8bc23292 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | TRANDOLAPRIL |
| Trandolapril | TRANDOLAPRIL | Aurobindo Pharma Limited | 6f25ed16-e5e9-4170-b4b4-3b460887779e | 2024-04-18 | Boxed warning, Warnings, Adverse reactions | TRANDOLAPRIL |
| Trandolapril | TRANDOLAPRIL | Rising Pharma Holdings, Inc. | 0107d19a-b43a-4a36-8b8c-4dfc247630e9 | 2024-04-18 | Boxed warning, Warnings, Adverse reactions | TRANDOLAPRIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49247 | SUPPL | 2017-08-04 |
| 49237 | SUPPL | 2017-08-04 |
| 12689 | SUPPL | 2016-02-02 |
| 25127 | SUPPL | 2016-02-01 |
| 34786 | SUPPL | 2015-01-09 |
| 25126 | SUPPL | 2014-12-30 |
| 34785 | SUPPL | 2012-09-14 |
| 25125 | SUPPL | 2012-09-14 |
| 12688 | SUPPL | 2012-03-06 |
| 25124 | SUPPL | 2012-01-30 |
| 2678 | SUPPL | 2012-01-30 |
| 12687 | SUPPL | 2012-01-23 |
| 2677 | SUPPL | 2011-11-14 |
| 34784 | SUPPL | 2011-09-16 |
| 25123 | SUPPL | 2011-09-16 |
| 34782 | SUPPL | 2010-05-03 |
| 2676 | SUPPL | 2010-04-23 |
| 34783 | SUPPL | 2009-04-16 |
| 25122 | SUPPL | 2009-04-16 |
| 23583 | ORIG | 2006-06-09 |
| 2675 | SUPPL | 2004-03-03 |
| 41416 | SUPPL | 1997-07-02 |
| 57459 | ORIG | 1996-04-26 |