Application 075657
- Type
- ANDA
- Sponsor
- TARO
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 |
|---|---|---|---|---|---|---|---|
| A075657-001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | |
| A075657-002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | |
| A075657-003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | |
| A075657-004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075657-001 | AB |
| A075657-002 | AB |
| A075657-003 | AB |
| A075657-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2001-01-23 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075657-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075657-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075657-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075657-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075657-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075657-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075657-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075657-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075657-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075657-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075657-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075657-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075657-004 | AB | 1 | 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 | Bryant Ranch Prepack | fb3c7066-76cb-4e8e-b98b-bcb41a3631df | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 63629-7895 |
| Enalapril Maleate | ENALAPRIL MALEATE | Sun Pharmaceutical Industries, Inc. | f103b9f9-e081-419d-a2d8-b86acda834dd | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 51672-4039 51672-4038 51672-4040 51672-4037 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | bc875f91-d781-43a9-8f7e-e2cfc019ad3f | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 50090-4560 |
| Enalapril Maleate | ENALAPRIL MALEATE | Northwind Health Company, LLC | ab2ffb6e-4628-e44c-e053-2a95a90a2336 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 51655-341 |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | 3fbc6cce-7ad5-49d5-9705-5f66ef92d544 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Golden State Medical Supply, Inc. | 0a12343f-5733-40cc-93b4-a02f5147fb91 | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 60429-184 60429-186 60429-183 60429-185 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | bdb34c96-1532-4ce5-93a7-3cc90904c910 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 71335-1910 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 2061543d-67e7-46b6-aa56-cafa11ae4b93 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | 0ad4bfb4-62db-4759-af60-88eb031d125a | 2023-12-12 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 50090-3378 |
| Enalapril Maleate | ENALAPRIL MALEATE | Golden State Medical Supply, Inc. | 074fe718-88d8-365c-e063-6394a90a299d | 2023-10-09 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | A-S Medication Solutions | f3754f29-9b75-4e2c-9c28-b3479f5bf906 | 2023-10-02 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | b4b7b936-4a62-4991-8d3c-03bb37f044c1 | 2023-10-02 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 |
| Enalapril Maleate | ENALAPRIL MALEATE | Proficient Rx LP | ca1d0143-bbd3-4041-9981-eadbb8893a2b | 2020-03-01 | Boxed warning, Warnings, Adverse reactions | 075657 ANDA075657 63187-977 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-195 | Enalapril Maleate | Enalapril Maleate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-293 | Enalapril Maleate | Enalapril Maleate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-632 | Enalapril Maleate | Enalapril Maleate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-633 | Enalapril Maleate | Enalapril Maleate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 50090-3275 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-3275 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-3275 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-3378 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-3378 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-3378 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-3378 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-3386 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 50090-4560 | Enalapril Maleate | Enalapril Maleate | A-S Medication Solutions | ANDA | Current |
| 51655-341 | Enalapril Maleate | Enalapril Maleate | Northwind Pharmaceuticals | ANDA | Current |
| 51655-341 | Enalapril Maleate | Enalapril Maleate | Northwind Pharmaceuticals | ANDA | Current |
| 51672-4037 | Enalapril Maleate | Enalapril Maleate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4038 | Enalapril Maleate | Enalapril Maleate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4039 | Enalapril Maleate | Enalapril Maleate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4040 | Enalapril Maleate | Enalapril Maleate | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 53808-1108 | Enalapril Maleate | Enalapril Maleate | DOH CENTRAL PHARMACY | ANDA | Current |
| 60429-183 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-183 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-183 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-183 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-184 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-184 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-184 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-184 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-185 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-185 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-185 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-185 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-186 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-186 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-186 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-186 | Enalapril Maleate | Enalapril Maleate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60760-587 | Enalapril Maleate | Enalapril Maleate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-977 | Enalapril Maleate | Enalapril Maleate | Proficient Rx LP | ANDA | Current |
| 63187-977 | Enalapril Maleate | Enalapril Maleate | Proficient Rx LP | ANDA | Current |
| 63187-977 | Enalapril Maleate | Enalapril Maleate | Proficient Rx LP | ANDA | Current |
| 63629-7895 | Enalapril Maleate | Enalapril Maleate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7895 | Enalapril Maleate | Enalapril Maleate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7895 | Enalapril Maleate | Enalapril Maleate | Bryant Ranch Prepack | ANDA | Current |
| 68071-2430 | Enalapril Maleate | Enalapril Maleate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7967 | Enalapril Maleate | Enalapril Maleate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7967 | Enalapril Maleate | Enalapril Maleate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8284 | Enalapril Maleate | Enalapril Maleate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0045 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0045 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0045 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0045 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0045 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0045 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0045 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1339 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1339 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1351 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1351 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1374 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1374 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1564 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1564 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1564 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1564 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1564 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1564 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1664 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1664 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1664 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1664 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1664 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 70934-492 | Enalapril Maleate | Enalapril Maleate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-526 | Enalapril Maleate | Enalapril Maleate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-566 | Enalapril Maleate | Enalapril Maleate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-689 | Enalapril Maleate | Enalapril Maleate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-702 | Enalapril Maleate | Enalapril Maleate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-713 | Enalapril Maleate | Enalapril Maleate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-1854 | Enalapril Maleate | Enalapril Maleate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1910 | Enalapril Maleate | Enalapril Maleate | Bryant Ranch Prepack | ANDA | Current |
| 72189-151 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | direct rx | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30975 | ORIG | 2001-01-23 |