Application 205787

Type: NDA
Sponsor: KALEO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVZIO	NALOXONE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	0.4MG/0.4ML (0.4MG/0.4ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205787-001	EVZIO	NALOXONE HYDROCHLORIDE	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2014-04-03

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205787-001	9278182	2026-02-01		Drug product	2016-04-11
N205787-001	8926594	2026-03-31		Drug product	2015-01-16
N205787-001	7731686	2026-06-10		Drug product	2014-05-23
N205787-001	10960155	2026-06-25		Drug product	2021-04-22
N205787-001	11590286	2026-12-12		Drug product	2023-03-29
N205787-001	9238108	2027-02-20		Drug product	2016-02-05
N205787-001	8206360	2027-02-27		Drug product	2014-05-23
N205787-001	9724471	2027-05-23	U-2092	Drug product	2017-08-23
N205787-001	7947017	2028-03-12		Drug product	2014-05-23
N205787-001	7749194	2028-10-30		Drug product	2014-05-23
N205787-001	8231573	2028-11-25		Drug product	2014-05-23
N205787-001	8226610	2029-04-10		Drug product	2014-05-23
N205787-001	8021344	2029-11-02		Drug product	2014-05-23
N205787-001	10322239	2031-02-28	U-1907		2019-06-19
N205787-001	8939943	2031-02-28		Drug product	2015-03-27
N205787-001	9022022	2031-02-28		Drug product	2015-05-15
N205787-001	9474869	2031-02-28	U-1907	Drug product	2016-11-02
N205787-001	10143972	2031-05-24	U-2476		2019-01-02
N205787-001	8627816	2032-02-04		Drug product	2014-05-23
N205787-001	9517307	2034-07-18	U-1925	Drug product	2016-12-19
N205787-001	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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,305 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205787-001	9278182	2026-02-01		Drug product	2016-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	8926594	2026-03-31		Drug product	2015-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	7731686	2026-06-10		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	10960155	2026-06-25		Drug product	2021-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	11590286	2026-12-12		Drug product	2023-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	9238108	2027-02-20		Drug product	2016-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	8206360	2027-02-27		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	9724471	2027-05-23	U-2092	Drug product	2017-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	7947017	2028-03-12		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	7749194	2028-10-30		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	8231573	2028-11-25		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	8226610	2029-04-10		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	8021344	2029-11-02		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	10322239	2031-02-28	U-1907		2019-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	8939943	2031-02-28		Drug product	2015-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	9022022	2031-02-28		Drug product	2015-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	9474869	2031-02-28	U-1907	Drug product	2016-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	10143972	2031-05-24	U-2476		2019-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	8627816	2032-02-04		Drug product	2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	9517307	2034-07-18	U-1925	Drug product	2016-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205787-001	10220158	2035-03-20	U-2500	Drug product	2019-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205787-001	9278182	2026-02-01		Drug product	2016-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	8926594	2026-03-31		Drug product	2015-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	7731686	2026-06-10		Drug product	2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	10960155	2026-06-25		Drug product	2021-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	11590286	2026-12-12		Drug product	2023-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	9238108	2027-02-20		Drug product	2016-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	8206360	2027-02-27		Drug product	2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	9724471	2027-05-23	U-2092	Drug product	2017-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	7947017	2028-03-12		Drug product	2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	7749194	2028-10-30		Drug product	2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	8231573	2028-11-25		Drug product	2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	8226610	2029-04-10		Drug product	2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	8021344	2029-11-02		Drug product	2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	10322239	2031-02-28	U-1907		2019-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	8939943	2031-02-28		Drug product	2015-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	9022022	2031-02-28		Drug product	2015-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	9474869	2031-02-28	U-1907	Drug product	2016-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	10143972	2031-05-24	U-2476		2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205787-001	8627816	2032-02-04		Drug product	2014-05-23	`caaa826d4ba7…`

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.

Matched openFDA labels page 2 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Henry Schein, Inc.	ddeebc32-9aab-4a2f-8c87-74335d17d5ef	2025-10-28	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	ProPharma Distribution	3f2bb95a-aeca-c0b7-e063-6394a90a627b	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e6467385-6990-498c-8a0e-f4a40ef33cb7	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	AMERISOURCE BERGEN	cce38c13-0d2f-49bb-94fa-6f2bbb4d5984	2025-08-31	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	3ba53405-5e72-c035-e063-6294a90ac0b1	2025-08-05	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	201fdedf-1736-4e52-9d7d-de14292547fd	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	ProPharma Distribution	3856ea66-29b8-8fc2-e063-6394a90ac33a	2025-07-18	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Eugia US LLC	8bcf426a-b4fc-4f24-9ad0-fb26168a0b56	2025-05-14	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	NorthStar RxLLC	d4c44b74-4e36-4b63-80eb-64ce99ccb39f	2025-01-27	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Henry Schein, Inc.	d39635a4-ddb3-4d32-8211-eb84c78e9f59	2025-01-27	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9bcff682-1196-7cef-e053-2a95a90aa954	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	International Medication Systems, Limited	236349ef-2cb5-47ca-a3a5-99534c3a4996	2024-12-16	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	28f3e3bc-b1be-9f06-e063-6394a90a1936	2024-12-10	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Asclemed USA, Inc.	7acf3bde-f858-4fbc-8a11-6741a3d27b8e	2024-10-29	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	Baxter Healthcare Corporation	48137634-91d7-41e3-b54b-e4321d69668a	2024-10-04	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Bryant Ranch Prepack	ed549649-dcbd-41f7-a774-876906751c5a	2024-10-03	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Eugia US LLC	c7fa8d4f-28a7-4ef5-aef8-cbd4328ce599	2024-07-06	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Eugia US LLC	2725b9c0-5b1e-498b-9ec5-ee76a62e656a	2024-07-06	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1be2e38b-55ca-abea-e063-6394a90ac548	2024-06-27	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	19b0603b-241f-f439-e063-6294a90ae85f	2024-05-30	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23003	ORIG	2014-12-18
32727	ORIG	2014-04-03
24505	ORIG	2014-04-03
19685	ORIG	2014-04-03