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 | REMEDYREPACK INC. | 3fbc6cce-7ad5-49d5-9705-5f66ef92d544 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | 5118eb9f-1466-4318-b17e-cf5898edbeef | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | a5c6e64c-a3ed-44f2-83e7-f4b62b6cd622 | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | 7077d32e-4b06-4d48-ba0c-6db2f8ebe08c | 2026-08-28 | Warnings, Adverse reactions | Enalapril maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Coupler LLC | 59f44ba0-a323-493f-e063-6394a90a1c3c | 2026-08-26 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | e47afc0d-afc4-4972-a28a-5d3c640390ab | 2026-08-26 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | b4b7b936-4a62-4991-8d3c-03bb37f044c1 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | bdb34c96-1532-4ce5-93a7-3cc90904c910 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | Enalapril Maleate ENALAPRIL MALEATE |
| 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 | Golden State Medical Supply, Inc. | 0a12343f-5733-40cc-93b4-a02f5147fb91 | 2026-08-05 | 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 | Golden State Medical Supply, Inc. | 074fe718-88d8-365c-e063-6394a90a299d | 2026-07-28 | 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 | 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 |
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 |
|---|---|---|---|---|---|
| 61919-690 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | DIRECT RX | ANDA | Current |
| 63187-397 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Proficient Rx LP | ANDA | Current |
| 63187-397 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Proficient Rx LP | ANDA | Current |
| 63629-1522 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1522 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1522 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1525 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1526 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1526 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1526 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Bryant Ranch Prepack | ANDA | Current |
| 64679-923 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-923 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-923 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-924 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-924 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-924 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-925 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-925 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-925 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-926 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-926 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64679-926 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Wockhardt USA LLC. | ANDA | Current |
| 64725-0924 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TYA Pharmaceuticals | ANDA | Current |
| 66267-323 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-323 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-380 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-380 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-413 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66336-393 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Dispensing Solutions, Inc. | ANDA | Current |
| 67046-156 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-160 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-161 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0756 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0756 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0756 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1936 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1936 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1938 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2618 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2670 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2670 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-390 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | American Health Packaging | ANDA | Current |
| 68084-391 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | American Health Packaging | ANDA | Current |
| 68084-392 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | American Health Packaging | ANDA | Current |
| 68645-455 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-455 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-455 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-455 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-456 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-456 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-456 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-456 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-457 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-457 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-457 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-457 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-7671 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7671 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7671 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-8061 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8061 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8096 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8096 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9931 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9932 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9933 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0028 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0028 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0028 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0028 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0028 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0028 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0046 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1957 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2445 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2445 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2445 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2445 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2621 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2621 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30909 | ORIG | 2000-08-22 |