Application 072115

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/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
A072115-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION			1988-04-27

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072115-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	1988-04-27	`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 4 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NARCAN	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	139c30b9-5600-48f5-8610-0cacd2782398	2023-09-28	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Hospira, Inc.	b598c237-032d-4bb5-0e92-50eabd863dac	2023-06-04	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	3d2dcee4-7510-477b-95a8-9b2afb773984	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	958577c3-d2c4-26ad-e053-2a95a90ad73a	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e53f169-4a6e-6102-e053-2995a90ab3dc	2023-05-09	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ada6856c-5293-fc2f-e053-2995a90a8ec6	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	b621239f-0bbb-7d07-e053-2a95a90a287e	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8959171f-eda6-158c-e053-2995a90a36b2	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	fa1ca55b-f56b-0d9b-e053-6294a90a258a	2023-04-24	Warnings, Adverse reactions	Name fallback brand name: naloxone hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ea4ea2fe-af48-0b3c-e053-2a95a90a0ad5	2023-04-24	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	f9c5efca-443a-41a0-e053-6294a90a8774	2023-04-20	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	74fcd243-94b3-ec77-e053-2991aa0a229c	2022-12-09	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Proficient Rx LP	8d529b4c-85fd-4e50-9443-9080825307bf	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Narcan	NALOXONE HYDROCHLORIDE	Proficient Rx LP	76b5a1ce-e601-457c-ab35-43533bba4394	2022-08-01	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride Injection, USP, Auto-Injector	NALOXONE HYDROCHLORIDE	Kaleo, Inc.	b5463553-b775-47a3-8d10-31e01ca1ec72	2022-03-11	Warnings, Adverse reactions	Name fallback generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	International Medication Systems, Limited	d2f5bfa0-933e-46d0-8b1a-9f90e6aaba54	2021-12-13	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
naloxone hydrochloride	NALOXONE HYDROCHLORIDE	Baxter Healthcare Corporation	d04ae2d7-01b9-405d-bb7a-bf2d876ce26a	2021-07-02	Warnings, Adverse reactions	Name fallback brand name: naloxone hydrochloride generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Mylan Institutional LLC	d96ebf2e-1051-4b5b-b1c6-2543dbbb2d04	2021-04-21	Warnings, Adverse reactions	Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	Baxter Healthcare Corporation	3d8813be-6d22-46f1-ac25-0d8a817a521c	2020-11-25	Warnings, Adverse reactions	Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Mylan Institutional LLC	f0932877-1f3b-4d5e-82d2-dd6c53db4730	2020-08-17	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.