Application 075483
- Type
- ANDA
- Sponsor
- WOCKHARDT LTD
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 |
|---|---|---|---|---|---|---|---|
| A075483-001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | |
| A075483-002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | |
| A075483-003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | |
| A075483-004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075483-001 | AB |
| A075483-002 | AB |
| A075483-003 | AB |
| A075483-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2000-08-22 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075483-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075483-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075483-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075483-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075483-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075483-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075483-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075483-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075483-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075483-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075483-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075483-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075483-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075483-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075483-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075483-004 | AB | 1 | 5bbf6a4d5a75… |
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 | 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 | 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 |
| Enalapril maleate | ENALAPRIL MALEATE | Major Pharmaceuticals | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 2026-01-30 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Vasotec | ENALAPRIL MALEATE | Bausch Health US LLC | 39631f1f-5d19-43c1-b504-bf56d991ed97 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | bc875f91-d781-43a9-8f7e-e2cfc019ad3f | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | ab2ffb6e-4628-e44c-e053-2a95a90a2336 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | f29ef93b-7380-2196-e053-2995a90a2ce3 | 2026-01-01 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | f2a0bd73-0389-3f88-e053-2995a90a72e8 | 2026-01-01 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | f2b3776b-02a1-311b-e053-2a95a90a2f9b | 2026-01-01 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 5c49fb37-1f09-4965-b213-5580d3a30a11 | 2025-12-30 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | Wilshire Pharmaceuticals, Inc. | c7934b45-eb6b-44c1-bd2c-ef0fa10850c1 | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Epaned | ENALAPRIL MALEATE | Azurity Pharmaceuticals, Inc. | e6dbda02-779e-420c-893d-d0fea09432be | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | aafdb635-fa17-4bfb-bcd3-86c7e7b147e2 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
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 |
|---|---|---|---|---|---|
| 0615-4589 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4590 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4591 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4593 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-5502 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 0904-5502 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 0904-5609 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 0904-5609 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 0904-5610 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 0904-5610 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 0904-5611 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 0904-5611 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Major Pharmaceuticals | ANDA | Current |
| 10544-170 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-487 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Rebel Distributors Corp | ANDA | Current |
| 21695-488 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Rebel Distributors Corp | ANDA | Current |
| 21695-489 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Rebel Distributors Corp | ANDA | Current |
| 35356-869 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-869 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-871 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-871 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-871 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-871 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 45865-404 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Medsource Pharmaceuticals | ANDA | Current |
| 50090-0689 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0689 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0689 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0690 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0690 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0690 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0692 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0692 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0692 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0692 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0692 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50090-0692 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | A-S Medication Solutions | ANDA | Current |
| 50436-4353 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Unit Dose Services | ANDA | Current |
| 51138-033 | Enalapril Maleate | Enalapril Maleate | Med Health Pharma, LLC | ANDA | Current |
| 51138-034 | Enalapril Maleate | Enalapril Maleate | Med Health Pharma, LLC | ANDA | Current |
| 51138-035 | Enalapril Maleate | Enalapril Maleate | Med Health Pharma, LLC | ANDA | Current |
| 51138-036 | Enalapril Maleate | Enalapril Maleate | Med Health Pharma, LLC | ANDA | Current |
| 51655-279 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53808-0242 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0243 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0244 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0966 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55289-591 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-591 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-591 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-591 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-591 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-591 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-694 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-694 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-694 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-694 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-694 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-984 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-984 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-984 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-984 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-984 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55648-923 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt Limited | ANDA | Current |
| 55648-924 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt Limited | ANDA | Current |
| 55648-925 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt Limited | ANDA | Current |
| 55648-926 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt Limited | ANDA | Current |
| 60760-226 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-226 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-226 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-227 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | St Marys Medical Park Pharmacy | ANDA | Current |
| 61919-277 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DirectRX | ANDA | Current |
| 61919-277 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DirectRX | ANDA | Current |
| 61919-277 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DirectRX | ANDA | Current |
| 61919-372 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
| 61919-372 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
| 61919-372 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Direct_Rx | ANDA | Current |
| 61919-372 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
| 61919-372 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
| 61919-690 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
| 61919-690 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
| 61919-690 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30909 | ORIG | 2000-08-22 |