Application 207634

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
A207634-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP		2017-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207634-001	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	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207634-001	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP	2017-07-26	`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	A207634-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207634-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207634-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207634-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207634-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207634-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207634-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207634-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207634-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207634-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207634-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207634-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207634-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207634-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207634-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207634-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207634-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207634-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207634-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207634-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207634-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207634-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207634-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207634-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207634-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207634-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207634-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207634-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207634-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207634-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207634-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207634-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207634-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207634-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207634-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207634-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207634-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207634-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207634-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207634-001	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	HF Acquisition Co. LLC. DBA HealthFirst	4d66b96a-acbb-2292-e063-6294a90af788	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207634 application number: ANDA207634
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	ProPharma Distribution	3f2bb95a-aeca-c0b7-e063-6394a90a627b	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207634 application number: ANDA207634
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9bcff682-1196-7cef-e053-2a95a90aa954	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207634 application number: ANDA207634 ndc (product): 51662-1426
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	28f3e3bc-b1be-9f06-e063-6394a90a1936	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207634 application number: ANDA207634
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Somerset Therapeutics, LLC	b59ee3cc-9604-4abc-81be-897e2f42aa67	2023-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207634 application number: ANDA207634 ndc (product): 70069-072

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1426	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1426	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
70069-072	Naloxone Hydrochloride	Naloxone Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-072	Naloxone Hydrochloride	Naloxone Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-072	Naloxone Hydrochloride	Naloxone Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current