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 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205787-001	EVZIO	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2014-04-03	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,326 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N205787-001	9278182	2026-02-01		Drug product	2016-04-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	8926594	2026-03-31		Drug product	2015-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	7731686	2026-06-10		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	10960155	2026-06-25		Drug product	2021-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	11590286	2026-12-12		Drug product	2023-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	9238108	2027-02-20		Drug product	2016-02-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	8206360	2027-02-27		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	9724471	2027-05-23	U-2092	Drug product	2017-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	7947017	2028-03-12		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	7749194	2028-10-30		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	8231573	2028-11-25		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	8226610	2029-04-10		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	8021344	2029-11-02		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	10322239	2031-02-28	U-1907		2019-06-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	8939943	2031-02-28		Drug product	2015-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	9022022	2031-02-28		Drug product	2015-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	9474869	2031-02-28	U-1907	Drug product	2016-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	10143972	2031-05-24	U-2476		2019-01-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	8627816	2032-02-04		Drug product	2014-05-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	9517307	2034-07-18	U-1925	Drug product	2016-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205787-001	10220158	2035-03-20	U-2500	Drug product	2019-03-27	`c2088c7a36db…`
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…`

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 1 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	8091a73d-9ecd-4578-a57b-5d85a2c5a16a	2026-08-25	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Sportpharm LLC	3750bf77-342c-4469-8bbb-f71009aa03fa	2026-07-02	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	53ed164c-dd09-4ea4-e063-6294a90a2434	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	5906381c-81f4-4635-867a-e56e4d629692	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Hospira, Inc.	8535cc84-ad4a-4d67-8480-fb5a2e3406f8	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Somerset Therapeutics, LLC	dfa48492-d83b-48cc-9ad1-bdc0c2ac9931	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	BluePoint Laboratories	327004b0-560a-84d0-e063-6294a90aa743	2026-04-02	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC. DBA HealthFirst	4d66b96a-acbb-2292-e063-6294a90af788	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Henry Schein, Inc	bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	REMEDYREPACK INC.	68df290c-d776-4cfc-9565-332eb56c4723	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	Lifestar Pharma LLC	aef6719c-cd71-46ee-b7b1-1806b939bf3e	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	AvKARE	1766a7f1-d301-945f-e063-6294a90ac6f4	2026-01-14	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
RiVive	NALOXONE HYDROCHLORIDE	Harm Reduction Therapeutics, Inc.	1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d	2026-01-13	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Sina Health Inc	2879294f-9af9-459e-e063-6394a90a0820	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	b5d40220-f194-4835-b70c-f304ecb222d5	2026-01-06	Warnings	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Dr. Reddy's Laboratories, Inc.	b1303f15-c48b-a44d-b28a-72f370094e02	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	BPI Labs LLC	5de44ee7-6525-4857-9a67-8882e96dbeb5	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Narcan	NALOXONE HYDROCHLORIDE	Emergent Devices Inc.	724df050-5332-4d0a-9a5f-17bf08a547e1	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
ZIMHI	NALOXONE HYDROCHLORIDE	ZMI Pharma Inc.	523c0909-bff6-4010-988a-53de18b7cb3f	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Strategic Sourcing Services LLC	577fbd57-7054-4536-86c1-d43bc99cc7b1	2025-11-19	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