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 | A-S Medication Solutions | fd0a7ecc-d6a2-4e04-a14f-1ed4dacb7df3 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | Rising Pharma Holdings, Inc. | 71e9fff3-7283-437e-b107-72fc16f09989 | 2025-10-03 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | ec6c8c65-b438-40e3-9eb3-665d939abbdb | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 4f56955c-fc61-49ad-b42f-ff9d3386af6a | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | fd013f06-3456-c178-e053-6294a90a6bd9 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | 0b3dbe11-ff75-cb98-e063-6294a90ad2e9 | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Northstar RxLLC | e109e7b1-4650-4416-9d89-7c1185d5cf48 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Coupler LLC | 2cc892e2-1d91-e52a-e063-6394a90a6649 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | fe2dfa84-0276-6603-e053-6394a90af8ee | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | dfc439f7-83f5-4b9e-bbf2-f3d002860be3 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | Chartwell RX, LLC | b1df1832-dce4-443f-87fc-e4177d069035 | 2024-10-09 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril maleate oral solution | ENALAPRIL MALEATE | Bionpharma Inc. | 9391b8d8-2217-4838-8976-1a5ad90ef4ca | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE |
| Enalapril maleate oral solution | ENALAPRIL MALEATE | NorthStar RxLLC | 19606da3-c6b0-40a5-9690-77fc37072b51 | 2024-04-18 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 2061543d-67e7-46b6-aa56-cafa11ae4b93 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | Aurobindo Pharma Limited | 337707cc-4ed9-4121-bfff-c5015e5eca9d | 2024-01-18 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | 0ad4bfb4-62db-4759-af60-88eb031d125a | 2023-12-12 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | f3754f29-9b75-4e2c-9c28-b3479f5bf906 | 2023-10-02 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | 7b80abb4-fa75-48a4-a2e9-b0e31205234c | 2023-05-23 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | A-S Medication Solutions | ccdd0f67-e9d5-41e3-93d5-94b9792a6f8f | 2023-04-27 | 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 |