Application 207633

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

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 1.

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
A207633-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP		2017-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A207633-001	AP

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207633-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-08-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207633-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207633-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207633-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207633-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207633-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207633-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207633-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207633-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207633-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207633-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207633-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207633-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207633-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207633-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207633-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207633-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207633-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207633-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207633-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207633-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207633-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207633-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207633-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207633-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207633-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207633-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207633-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207633-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207633-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207633-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207633-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207633-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207633-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207633-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207633-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207633-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207633-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207633-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207633-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207633-001	AP	1	`cb3db0bc1861…`

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	5906381c-81f4-4635-867a-e56e4d629692	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207633 application number: ANDA207633 ndc (product): 50090-5427
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Somerset Therapeutics, LLC	dfa48492-d83b-48cc-9ad1-bdc0c2ac9931	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207633 application number: ANDA207633 ndc (product): 70069-071
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Sina Health Inc	2879294f-9af9-459e-e063-6394a90a0820	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207633 application number: ANDA207633
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	ProPharma Distribution	3856ea66-29b8-8fc2-e063-6394a90ac33a	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207633 application number: ANDA207633
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e53f169-4a6e-6102-e053-2995a90ab3dc	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207633 application number: ANDA207633 ndc (product): 71872-7198

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9923	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9923	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	Henry Schein, Inc.	ANDA	Current
50090-5427	Naloxone Hydrochloride	Naloxone Hydrochloride	A-S Medication Solutions	ANDA	Current
52584-120	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables and Vaccines, INC.	ANDA	Current
52584-120	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	General Injectables and Vaccines, INC.	ANDA	Current
70069-071	Naloxone Hydrochloride	Naloxone Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-071	Naloxone Hydrochloride	Naloxone Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-071	Naloxone Hydrochloride	Naloxone Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-071	Naloxone Hydrochloride	Naloxone Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
71872-7198	Naloxone Hydrochloride	Naloxone Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current