Application 209522

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	SPRAY, METERED;NASAL	4MG/SPRAY	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
A209522-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL			2019-04-19

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	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		2019-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209522-001	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL	AB	2019-04-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209522-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209522-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209522-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209522-001	AB	1	`bb7c543d1eb4…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209522-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209522-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209522-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209522-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209522-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209522-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209522-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209522-001	AB	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209522-001	PC	2022-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209522-001	PC	2022-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209522-001	PC	2022-06-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209522-001	PC	2022-06-20	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	A209522-001	PC	2022-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209522-001	PC	2022-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209522-001	PC	2022-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209522-001	PC	2022-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209522-001	PC	2022-06-20	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Sportpharm LLC	3750bf77-342c-4469-8bbb-f71009aa03fa	2026-07-02	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Asclemed USA, Inc.	7acf3bde-f858-4fbc-8a11-6741a3d27b8e	2024-10-29	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Actavis Pharma, Inc.	49350f7e-d613-40a8-8941-a2ec30eafdf3	2024-01-30	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Teva Pharmaceuticals, Inc.	3a73ee4b-c2a4-496f-be90-9f78c8046062	2024-01-01	Warnings	Exact identifier application applno (ANDA): 209522 application number: ANDA209522

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2165	Naloxone Hydrochloride	Naloxone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2165	Naloxone Hydrochloride	Naloxone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2165	Naloxone Hydrochloride	Naloxone Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58822	ORIG	2019-05-22