Application 087408

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML	No	Yes
002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087408-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
A087408-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087408-001	HYDROXYZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087408-002	HYDROXYZINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3a93d1ddd44b…`

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
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Henry Schein, Inc.	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408 ndc (product): 0404-9877
Hydroxyzine	HYDROXYZINE	Henry Schein, Inc.	851e7439-bb0a-4a09-9279-e3c33bff8965	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408 ndc (product): 0404-9878
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Regent, Inc.	8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408 ndc (product): 0517-5601 ndc (product): 0517-5602 ndc (product): 0517-4201
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	16a63845-6619-293b-e063-6394a90a0a5c	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087408 application number: ANDA087408

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9877	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9877	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9878	Hydroxyzine	Hydroxyzine	Henry Schein, Inc.	ANDA	Current
0404-9878	Hydroxyzine	Hydroxyzine	Henry Schein, Inc.	ANDA	Current
0517-4201	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-4201	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-4201	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-5601	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-5601	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-5601	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-5602	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-5602	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
0517-5602	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	American Regent, Inc.	ANDA	Current
52584-007	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-007	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-007	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-007	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-007	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-601	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-601	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-601	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-610	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-610	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current
52584-610	Hydroxyzine	Hydroxyzine	General Injectables & Vaccines, Inc	ANDA	Current