Application 207846

Type: ANDA
Sponsor: VIRTUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.4MG/ML	No	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
A207846-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION			2018-12-17

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2018-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2018-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207846-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION		2018-12-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A207846-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207846-001	AP	1	`ea99ee380514…`

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 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Strategic Sourcing Services LLC	577fbd57-7054-4536-86c1-d43bc99cc7b1	2025-11-19	Warnings	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Henry Schein, Inc.	ddeebc32-9aab-4a2f-8c87-74335d17d5ef	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	ProPharma Distribution	3f2bb95a-aeca-c0b7-e063-6394a90a627b	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride 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 brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	AMERISOURCE BERGEN	cce38c13-0d2f-49bb-94fa-6f2bbb4d5984	2025-08-31	Warnings	Name fallback brand name: NALOXONE HYDROCHLORIDE 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 brand name: NALOXONE HYDROCHLORIDE 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 brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	ProPharma Distribution	3856ea66-29b8-8fc2-e063-6394a90ac33a	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Eugia US LLC	8bcf426a-b4fc-4f24-9ad0-fb26168a0b56	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	NorthStar RxLLC	d4c44b74-4e36-4b63-80eb-64ce99ccb39f	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: naloxone hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Henry Schein, Inc.	d39635a4-ddb3-4d32-8211-eb84c78e9f59	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride 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 brand name: NALOXONE HYDROCHLORIDE 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 brand name: Naloxone Hydrochloride 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 brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Asclemed USA, Inc.	7acf3bde-f858-4fbc-8a11-6741a3d27b8e	2024-10-29	Warnings	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	Baxter Healthcare Corporation	48137634-91d7-41e3-b54b-e4321d69668a	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: naloxone hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Bryant Ranch Prepack	ed549649-dcbd-41f7-a774-876906751c5a	2024-10-03	Warnings	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Eugia US LLC	c7fa8d4f-28a7-4ef5-aef8-cbd4328ce599	2024-07-06	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Eugia US LLC	2725b9c0-5b1e-498b-9ec5-ee76a62e656a	2024-07-06	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1be2e38b-55ca-abea-e063-6394a90ac548	2024-06-27	Warnings	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70655-058	Naloxone HCl	Naloxone Hydrochloride	Renaissance SSA, LLC	ANDA	Current