Application 075480
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 2.5MG | No | No |
| 002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 5MG | No | No |
| 003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 10MG | No | No |
| 004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075480-001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | ||
| A075480-002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | ||
| A075480-003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | ||
| A075480-004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075480-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | 2000-08-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075480-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | 2000-08-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075480-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | 2000-08-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075480-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | 2000-08-22 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | 1b464099-491d-473b-836e-9d86b2b1eeec | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | fb3c7066-76cb-4e8e-b98b-bcb41a3631df | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | fa93d8e6-2ed2-4a3c-bf6d-33bd0a374efa | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | b31372f7-cda3-4ead-a481-4cde62e843fd | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | e47afc0d-afc4-4972-a28a-5d3c640390ab | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Sun Pharmaceutical Industries, Inc. | f103b9f9-e081-419d-a2d8-b86acda834dd | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | eee8633b-9d9e-453d-8c6b-8b13c94d2f58 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | ScieGen Pharmaceuticals, Inc. | 63187a94-9ac7-4320-ac70-0631e08c2b8d | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | St. Mary's Medical Park Pharmacy | ed266486-e4a5-9dd1-e053-2a95a90a80d3 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | c1e4cd79-ece5-432c-bd3a-ed4633ccec70 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Coupler LLC | 508a58fa-9f66-e984-e063-6394a90a296a | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | 5596ba00-4a1c-4503-99db-3a9617ed17c0 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Preferred Pharmaceuicals Inc. | 898b36d6-320f-4d6c-9734-0be8363dc3d7 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | 9e277302-6e6c-4a95-8f25-aaff64fb0b82 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | A-S Medication Solutions | 9f913e79-fe6d-4ff2-9f8e-eef9df689fa8 | 2026-03-17 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | 315baaa6-512c-f27b-e063-6294a90a2c91 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ed7536f1-9a7d-4519-e053-2a95a90a4a65 | 2026-03-11 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 2a8ca159-c4c7-468a-bcc2-d1b879ea2c7e | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Solco Healthcare US, LLC | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 2026-01-31 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1052 | Enalapril Maleate | Enalapril Maleate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1052 | Enalapril Maleate | Enalapril Maleate | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0615-7907 | Enalapril Maleate | Enalapril Maleate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7908 | Enalapril Maleate | Enalapril Maleate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7909 | Enalapril Maleate | Enalapril Maleate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 51079-951 | Enalapril Maleate | Enalapril Maleate | Mylan Institutional Inc. | ANDA | Current |
| 67046-157 | Enalapril Maleate | Enalapril Maleate | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-158 | Enalapril Maleate | Enalapril Maleate | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-159 | Enalapril Maleate | Enalapril Maleate | Contract Pharmacy Services-PA | ANDA | Current |
| 70518-0592 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0623 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |