Application 213273
- Type
- ANDA
- Sponsor
- PRINSTON INC
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 |
|---|---|---|---|---|---|---|---|
| A213273-001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | |
| A213273-002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | |
| A213273-003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | |
| A213273-004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213273-001 | AB |
| A213273-002 | AB |
| A213273-003 | AB |
| A213273-004 | 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 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-001 | ENALAPRIL MALEATE | 2.5MG | TABLET / ORAL | AB | 2022-07-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-002 | ENALAPRIL MALEATE | 5MG | TABLET / ORAL | AB | 2022-07-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-003 | ENALAPRIL MALEATE | 10MG | TABLET / ORAL | AB | 2022-07-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-004 | ENALAPRIL MALEATE | 20MG | TABLET / ORAL | AB | 2022-07-07 | 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 | A213273-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213273-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213273-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213273-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213273-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213273-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213273-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213273-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213273-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213273-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213273-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213273-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213273-004 | 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 | REMEDYREPACK INC. | 1b464099-491d-473b-836e-9d86b2b1eeec | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 70518-3572 |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | e47afc0d-afc4-4972-a28a-5d3c640390ab | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | St. Mary's Medical Park Pharmacy | ed266486-e4a5-9dd1-e053-2a95a90a80d3 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 60760-575 |
| Enalapril Maleate | ENALAPRIL MALEATE | Coupler LLC | 508a58fa-9f66-e984-e063-6394a90a296a | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | 5596ba00-4a1c-4503-99db-3a9617ed17c0 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Preferred Pharmaceuicals Inc. | 898b36d6-320f-4d6c-9734-0be8363dc3d7 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Preferred Pharmaceuticals Inc. | 9e277302-6e6c-4a95-8f25-aaff64fb0b82 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | NuCare Pharmaceuticals, Inc. | 315baaa6-512c-f27b-e063-6294a90a2c91 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 2a8ca159-c4c7-468a-bcc2-d1b879ea2c7e | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Solco Healthcare US, LLC | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 2026-01-31 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 43547-545 43547-547 43547-548 43547-546 |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | 5118eb9f-1466-4318-b17e-cf5898edbeef | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | REMEDYREPACK INC. | a5c6e64c-a3ed-44f2-83e7-f4b62b6cd622 | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | ec6c8c65-b438-40e3-9eb3-665d939abbdb | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 71335-9604 |
| Enalapril Maleate | ENALAPRIL MALEATE | Bryant Ranch Prepack | 4f56955c-fc61-49ad-b42f-ff9d3386af6a | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | fe303f6a-4a9f-259e-e053-6394a90af16b | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | PD-Rx Pharmaceuticals, Inc. | cbaaa849-0f9d-4294-b122-090ff17fdcc7 | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | fd013f06-3456-c178-e053-6294a90a6bd9 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | NuCare Pharmaceuticals,Inc. | 0b3dbe11-ff75-cb98-e063-6294a90ad2e9 | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
| Enalapril Maleate | ENALAPRIL MALEATE | Coupler LLC | 2cc892e2-1d91-e52a-e063-6394a90a6649 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | 213273 ANDA213273 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-545 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-546 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-547 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-548 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 60760-575 | Enalapril Maleate | Enalapril Maleate | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 60760-688 | Enalapril Maleate | Enalapril Maleate | St Mary's Medical Park Pharmacy | ANDA | Current |
| 70518-3572 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 71335-9604 | Enalapril Maleate | Enalapril Maleate | Bryant Ranch Prepack | ANDA | Current |