Application 072081

Type: ANDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.02MG/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
A072081-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION			1989-04-11

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072081-001	NALOXONE HYDROCHLORIDE	0.02MG/ML	INJECTABLE / INJECTION	1989-04-11	`f41ea6bd6efb…`

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 3 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	HF Acquisition Co LLC, DBA HealthFirst	19b0603b-241f-f439-e063-6294a90ae85f	2024-05-30	Warnings	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
REXTOVY	NALOXONE HYDROCHLORIDE	International Medication Systems, Ltd.	fe9735db-c57e-44a8-bffb-b87a84c2a6f3	2024-05-15	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	CVS Pharmacy, Inc	840e017d-0142-4d0e-a80e-327ac44bc0c5	2024-04-24	Warnings	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Walgreen Co.	3829826b-e48f-4e26-869f-6b9e4ee0a840	2024-04-24	Warnings	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE	Amneal Pharmaceuticals NY LLC	8779a073-dc6e-410a-9959-fd370f0079f9	2024-04-19	Warnings	Name fallback brand name: Naloxone Hydrochloride
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Mylan Institutional LLC	7faaedb3-227b-408d-b772-6b326638b00e	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Par Health USA, LLC	3ae08e26-223b-4971-b2f1-f1e183a3f930	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1bef59b9-7d51-4f19-a054-44b8eb6c6398	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	Lifestar Pharma LLC	ef647e2a-84e7-4e3e-942a-b6fc250141b6	2024-03-04	Warnings, Adverse reactions	Name fallback brand name: naloxone hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c72a60fb-196d-3f02-e053-2995a90ad906	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	94ff1857-06da-7986-e053-2a95a90afb18	2024-02-19	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c90e2d85-ed94-2c00-e053-2a95a90ad2a0	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Actavis Pharma, Inc.	49350f7e-d613-40a8-8941-a2ec30eafdf3	2024-01-30	Warnings	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	e65e03c1-9a66-b30b-e053-2995a90aeb73	2024-01-27	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	74fc593e-ed47-efae-e053-2991aa0a5997	2024-01-25	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Teva Pharmaceuticals, Inc.	3a73ee4b-c2a4-496f-be90-9f78c8046062	2024-01-01	Warnings	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	46f27d04-d4d2-4ef1-9cc5-4d58f4056f06	2023-12-27	Warnings	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Somerset Therapeutics, LLC	b59ee3cc-9604-4abc-81be-897e2f42aa67	2023-12-19	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE NASAL	A-S Medication Solutions	4517afa1-4b17-4a15-b91b-65b18bd0558f	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	0b3b5214-6f91-4bba-82d6-d57b16845df5	2023-10-01	Warnings, Adverse reactions	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.