Application 213279

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A213279-001	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2021-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213279-001	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.

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	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213279-001	NALOXONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2021-01-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213279-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213279-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213279-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213279-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213279-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213279-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213279-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213279-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213279-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213279-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213279-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213279-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213279-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213279-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213279-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213279-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213279-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213279-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213279-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213279-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213279-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213279-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213279-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213279-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213279-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213279-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213279-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213279-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213279-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213279-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213279-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213279-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213279-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213279-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213279-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Eugia US LLC	8bcf426a-b4fc-4f24-9ad0-fb26168a0b56	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213279 application number: ANDA213279 ndc (product): 55150-345
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	e65e03c1-9a66-b30b-e053-2995a90aeb73	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213279 application number: ANDA213279 ndc (product): 51662-1586
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	f9c5efca-443a-41a0-e053-6294a90a8774	2023-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213279 application number: ANDA213279

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
51662-1586	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55150-345	Naloxone Hydrochloride	Naloxone Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-345	Naloxone Hydrochloride	Naloxone Hydrochloride	AuroMedics Pharma LLC	ANDA	Current