Application 209862
- Type
- NDA
- Sponsor
- KALEO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 2MG/0.4ML (2MG/0.4ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209862-001 | EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209862-001 | 9278182 | 2026-02-01 | Drug product | 2016-11-07 | |
| N209862-001 | 8926594 | 2026-03-31 | Drug product | 2016-11-07 | |
| N209862-001 | 7731686 | 2026-06-01 | Drug product | 2016-11-07 | |
| N209862-001 | 10960155 | 2026-06-25 | Drug product | 2021-04-22 | |
| N209862-001 | 11590286 | 2026-12-12 | Drug product | 2023-03-29 | |
| N209862-001 | 9238108 | 2027-02-20 | Drug product | 2016-11-07 | |
| N209862-001 | 8206360 | 2027-02-27 | Drug product | 2016-11-07 | |
| N209862-001 | 9724471 | 2027-05-23 | U-2092 | Drug product | 2017-08-23 |
| N209862-001 | 7947017 | 2028-03-12 | Drug product | 2016-11-07 | |
| N209862-001 | 7749194 | 2028-10-30 | Drug product | 2016-11-07 | |
| N209862-001 | 8231573 | 2028-11-25 | Drug product | 2016-11-07 | |
| N209862-001 | 8226610 | 2029-04-10 | Drug product | 2016-11-07 | |
| N209862-001 | 8021344 | 2029-11-02 | Drug product | 2016-11-07 | |
| N209862-001 | 10322239 | 2031-02-28 | U-1907 | 2019-06-19 | |
| N209862-001 | 8939943 | 2031-02-28 | Drug product | 2016-11-07 | |
| N209862-001 | 9022022 | 2031-02-28 | Drug product | 2016-11-07 | |
| N209862-001 | 9474869 | 2031-02-28 | U-1907 | Drug product | 2016-11-07 |
| N209862-001 | 10143792 | 2031-05-24 | U-2476 | 2019-01-02 | |
| N209862-001 | 8627816 | 2032-02-04 | Drug product | 2016-11-07 | |
| N209862-001 | 9517307 | 2034-07-18 | U-1925 | Drug product | 2016-12-19 |
| N209862-001 | 10220158 | 2035-03-20 | U-2500 | Drug product | 2019-03-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD, RS | 2016-10-19 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209862-001 | EVZIO (AUTOINJECTOR) | 2MG/0.4ML (2MG/0.4ML) | SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS | RLD | 2016-10-19 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9278182 | 2026-02-01 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8926594 | 2026-03-31 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 7731686 | 2026-06-01 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10960155 | 2026-06-25 | Drug product | 2021-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 11590286 | 2026-12-12 | Drug product | 2023-03-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9238108 | 2027-02-20 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8206360 | 2027-02-27 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9724471 | 2027-05-23 | U-2092 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 7947017 | 2028-03-12 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 7749194 | 2028-10-30 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8231573 | 2028-11-25 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8226610 | 2029-04-10 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8021344 | 2029-11-02 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10322239 | 2031-02-28 | U-1907 | 2019-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8939943 | 2031-02-28 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9022022 | 2031-02-28 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9474869 | 2031-02-28 | U-1907 | Drug product | 2016-11-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10143792 | 2031-05-24 | U-2476 | 2019-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 8627816 | 2032-02-04 | Drug product | 2016-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 9517307 | 2034-07-18 | U-1925 | Drug product | 2016-12-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209862-001 | 10220158 | 2035-03-20 | U-2500 | Drug product | 2019-03-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7731690 | 2025-01-15 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8016788 | 2025-03-21 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 10335549 | 2025-04-30 | Drug product | 2019-07-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9278182 | 2026-02-01 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8926594 | 2026-03-31 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7731686 | 2026-06-01 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 10960155 | 2026-06-25 | Drug product | 2021-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 11590286 | 2026-12-12 | Drug product | 2023-03-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9238108 | 2027-02-20 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8206360 | 2027-02-27 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9724471 | 2027-05-23 | U-2092 | Drug product | 2017-08-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7947017 | 2028-03-12 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 7749194 | 2028-10-30 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8231573 | 2028-11-25 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8226610 | 2029-04-10 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8021344 | 2029-11-02 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 10322239 | 2031-02-28 | U-1907 | 2019-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 8939943 | 2031-02-28 | Drug product | 2016-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209862-001 | 9022022 | 2031-02-28 | Drug product | 2016-11-07 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Sportpharm LLC | 3750bf77-342c-4469-8bbb-f71009aa03fa | 2026-07-02 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 53ed164c-dd09-4ea4-e063-6294a90a2434 | 2026-06-11 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 5906381c-81f4-4635-867a-e56e4d629692 | 2026-06-03 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Hospira, Inc. | 8535cc84-ad4a-4d67-8480-fb5a2e3406f8 | 2026-05-27 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Somerset Therapeutics, LLC | dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 | 2026-05-05 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | BluePoint Laboratories | 327004b0-560a-84d0-e063-6294a90aa743 | 2026-04-02 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co. LLC. DBA HealthFirst | 4d66b96a-acbb-2292-e063-6294a90af788 | 2026-03-19 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Henry Schein, Inc | bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc | 2026-03-02 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | REMEDYREPACK INC. | 68df290c-d776-4cfc-9565-332eb56c4723 | 2026-02-10 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Lifestar Pharma LLC | aef6719c-cd71-46ee-b7b1-1806b939bf3e | 2026-02-09 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | AvKARE | 1766a7f1-d301-945f-e063-6294a90ac6f4 | 2026-01-14 | Warnings | NALOXONE HYDROCHLORIDE |
| RiVive | NALOXONE HYDROCHLORIDE | Harm Reduction Therapeutics, Inc. | 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d | 2026-01-13 | Warnings | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Sina Health Inc | 2879294f-9af9-459e-e063-6394a90a0820 | 2026-01-12 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | b5d40220-f194-4835-b70c-f304ecb222d5 | 2026-01-06 | Warnings | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | BPI Labs LLC | 5de44ee7-6525-4857-9a67-8882e96dbeb5 | 2025-12-26 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 8091a73d-9ecd-4578-a57b-5d85a2c5a16a | 2025-12-09 | Warnings | NALOXONE HYDROCHLORIDE |
| Narcan | NALOXONE HYDROCHLORIDE | Emergent Devices Inc. | 724df050-5332-4d0a-9a5f-17bf08a547e1 | 2025-12-05 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| ZIMHI | NALOXONE HYDROCHLORIDE | ZMI Pharma Inc. | 523c0909-bff6-4010-988a-53de18b7cb3f | 2025-12-04 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Strategic Sourcing Services LLC | 577fbd57-7054-4536-86c1-d43bc99cc7b1 | 2025-11-19 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Henry Schein, Inc. | ddeebc32-9aab-4a2f-8c87-74335d17d5ef | 2025-10-28 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51662-1495 | EVZIO(R) NALOXONE HCl | EVZIO(R) NALOXONE HCl | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1495 | EVZIO(R) NALOXONE HCl | EVZIO(R) NALOXONE HCl | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 60842-051 | Evzio | naloxone hydrochloride | kaleo, Inc. | NDA | Current |
| 60842-051 | Evzio | naloxone hydrochloride | kaleo, Inc. | NDA | Current |
| 72853-051 | Naloxone Hydrochloride | naloxone hydrochloride | IJ Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |
| 72853-051 | Naloxone Hydrochloride | naloxone hydrochloride | IJ Therapeutics, LLC | NDA AUTHORIZED GENERIC | Current |