Application 070299

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALOXONE	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
A070299-001	NALOXONE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE / INJECTION	AP		1986-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070299-001	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	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070299-001	NALOXONE	0.4MG/ML	INJECTABLE / INJECTION	AP	1986-09-24	`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	A070299-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070299-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070299-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070299-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070299-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070299-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070299-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070299-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070299-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070299-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070299-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070299-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070299-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070299-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070299-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070299-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070299-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070299-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070299-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070299-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070299-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070299-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070299-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070299-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070299-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070299-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070299-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070299-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070299-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070299-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070299-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070299-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070299-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070299-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070299-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070299-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070299-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070299-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070299-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070299-001	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	NALXONE HYDROCHLORIDE	Civica, Inc.	21d20dff-6efe-481e-a5a0-9c80ded73ca9	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299 ndc (product): 72572-450
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	3ba53405-5e72-c035-e063-6294a90ac0b1	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1bef59b9-7d51-4f19-a054-44b8eb6c6398	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299 ndc (product): 0641-6260
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8959171f-eda6-158c-e053-2995a90a36b2	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299 ndc (product): 71872-7009
Naloxone Hydrochloride	NALXONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8cc25cf1-008c-4808-baec-49f35a887fae	2020-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070299 application number: ANDA070299 ndc (product): 0641-6132

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
0641-6132	Naloxone Hydrochloride	Nalxone Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6132	Naloxone Hydrochloride	Nalxone Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6260	Naloxone Hydrochloride	Nalxone Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
71872-7009	Naloxone Hydrochloride	Nalxone Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
72572-450	Naloxone Hydrochloride	Nalxone Hydrochloride	Civica, Inc.	ANDA	Current