Application 204308
- Type
- NDA
- Sponsor
- SILVERGATE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPANED KIT | ENALAPRIL MALEATE | FOR SOLUTION;ORAL | 1MG/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204308-001 | EPANED KIT | ENALAPRIL MALEATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204308-001 | 8568747 | 2032-11-06 | Drug product | 2013-10-31 | |
| N204308-001 | 8778366 | 2032-11-06 | U-1723 | 2014-07-16 | |
| N204308-001 | 8778366 | 2032-11-06 | U-185 | 2014-07-16 | |
| N204308-001 | 8778366 | 2032-11-06 | U-1892 | 2014-07-16 | |
| N204308-001 | 8778366 | 2032-11-06 | U-3 | 2014-07-16 | |
| N204308-001 | 8778366 | 2032-11-06 | U-71 | 2014-07-16 | |
| N204308-001 | 9855214 | 2032-11-06 | Drug product | 2018-01-10 | |
| N204308-001 | 9968553 | 2032-11-06 | U-1723 | 2018-06-01 | |
| N204308-001 | 9968553 | 2032-11-06 | U-185 | 2018-06-01 | |
| N204308-001 | 9968553 | 2032-11-06 | U-1892 | 2018-06-01 | |
| N204308-001 | 9968553 | 2032-11-06 | U-3 | 2018-06-01 | |
| N204308-001 | 9968553 | 2032-11-06 | U-71 | 2018-06-01 |
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| 2026-07 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N204308-001 | EPANED KIT | 1MG/ML | FOR SOLUTION / ORAL | RLD | 2013-08-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N204308-001 | EPANED KIT | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 2013-08-13 | e64feba35796… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 8568747 | 2032-11-06 | Drug product | 2013-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 8778366 | 2032-11-06 | U-3 | 2014-07-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 8778366 | 2032-11-06 | U-71 | 2014-07-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 8778366 | 2032-11-06 | U-185 | 2014-07-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 8778366 | 2032-11-06 | U-1723 | 2014-07-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 8778366 | 2032-11-06 | U-1892 | 2014-07-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 9855214 | 2032-11-06 | Drug product | 2018-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 9968553 | 2032-11-06 | U-71 | 2018-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 9968553 | 2032-11-06 | U-3 | 2018-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 9968553 | 2032-11-06 | U-1892 | 2018-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 9968553 | 2032-11-06 | U-185 | 2018-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204308-001 | 9968553 | 2032-11-06 | U-1723 | 2018-06-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 8568747 | 2032-11-06 | Drug product | 2013-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 8778366 | 2032-11-06 | U-3 | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 8778366 | 2032-11-06 | U-71 | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 8778366 | 2032-11-06 | U-185 | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 8778366 | 2032-11-06 | U-1723 | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 8778366 | 2032-11-06 | U-1892 | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 9855214 | 2032-11-06 | Drug product | 2018-01-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 9968553 | 2032-11-06 | U-71 | 2018-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 9968553 | 2032-11-06 | U-3 | 2018-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 9968553 | 2032-11-06 | U-1892 | 2018-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 9968553 | 2032-11-06 | U-185 | 2018-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204308-001 | 9968553 | 2032-11-06 | U-1723 | 2018-06-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 8568747 | 2032-11-06 | Drug product | 2013-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 8778366 | 2032-11-06 | U-3 | 2014-07-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 8778366 | 2032-11-06 | U-71 | 2014-07-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 8778366 | 2032-11-06 | U-185 | 2014-07-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 8778366 | 2032-11-06 | U-1723 | 2014-07-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 8778366 | 2032-11-06 | U-1892 | 2014-07-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 9855214 | 2032-11-06 | Drug product | 2018-01-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 9968553 | 2032-11-06 | U-71 | 2018-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 9968553 | 2032-11-06 | U-3 | 2018-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 9968553 | 2032-11-06 | U-1892 | 2018-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 9968553 | 2032-11-06 | U-185 | 2018-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204308-001 | 9968553 | 2032-11-06 | U-1723 | 2018-06-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204308-001 | 8568747 | 2032-11-06 | Drug product | 2013-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204308-001 | 8778366 | 2032-11-06 | U-3 | 2014-07-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204308-001 | 8778366 | 2032-11-06 | U-71 | 2014-07-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204308-001 | 8778366 | 2032-11-06 | U-185 | 2014-07-16 | 6a471c1ec25d… |
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 | 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 | Bryant Ranch Prepack | fa93d8e6-2ed2-4a3c-bf6d-33bd0a374efa | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 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 | REMEDYREPACK INC. | e47afc0d-afc4-4972-a28a-5d3c640390ab | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 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 | Preferred Pharmaceuticals Inc. | eee8633b-9d9e-453d-8c6b-8b13c94d2f58 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 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 | 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 | Bryant Ranch Prepack | c1e4cd79-ece5-432c-bd3a-ed4633ccec70 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE |
| 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 | Preferred Pharmaceuticals Inc. | 5596ba00-4a1c-4503-99db-3a9617ed17c0 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 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 | Preferred Pharmaceuticals Inc. | 9e277302-6e6c-4a95-8f25-aaff64fb0b82 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 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 | NuCare Pharmaceuticals, Inc. | 315baaa6-512c-f27b-e063-6294a90a2c91 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | 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 | Bryant Ranch Prepack | 7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 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 | Solco Healthcare US, LLC | 0c829189-fba2-48f8-a23f-d5471a0345f6 | 2026-01-31 | Boxed warning, Warnings, Adverse reactions | ENALAPRIL MALEATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52652-1001 | EPANED | enalapril maleate | Silvergate Pharmaceuticals, Inc. | NDA | Current |
| 52652-1001 | EPANED | enalapril maleate | Silvergate Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49184 | SUPPL | 2017-08-02 |
| 49152 | SUPPL | 2017-07-31 |
| 47679 | SUPPL | 2017-03-24 |
| 47655 | SUPPL | 2017-03-23 |
| 40374 | SUPPL | 2016-02-02 |
| 10321 | SUPPL | 2016-01-29 |
| 19544 | SUPPL | 2014-09-09 |
| 19543 | SUPPL | 2014-09-09 |
| 32542 | SUPPL | 2014-09-08 |
| 10320 | SUPPL | 2014-09-08 |
| 24466 | ORIG | 2014-06-27 |
| 22951 | ORIG | 2014-06-27 |
| 40373 | ORIG | 2013-08-15 |
| 10319 | ORIG | 2013-08-15 |