Application 040808

Type: ANDA
Sponsor: AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040808-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-09-24
A040808-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-09-24
A040808-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-09-24

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 4 · 129 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
2026-09-14 22:38:34	2026-08	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040808-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040808-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A040808-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040808-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040808-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040808-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040808-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040808-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040808-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040808-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040808-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040808-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040808-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040808-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040808-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040808-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040808-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040808-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040808-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040808-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040808-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040808-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040808-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040808-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040808-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040808-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040808-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040808-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040808-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040808-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040808-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040808-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040808-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040808-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040808-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040808-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040808-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040808-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040808-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040808-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040808-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040808-002	AB	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE	Amneal Pharmaceuticals LLC	89901966-724b-4773-98b8-ea663ceabd53	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040808 application number: ANDA040808 ndc (product): 65162-575 ndc (product): 65162-577 ndc (product): 65162-671

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 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-226	Hydroxyzine Hydrochloride	Hydroxyzine	Blenheim Pharmacal, Inc.	ANDA	Current
10544-227	Hydroxyzine Hydrochloride	Hydroxyzine	Blenheim Pharmacal, Inc.	ANDA	Current
43063-435	Hydroxyzine Hydrochloride	Hydroxyzine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-435	Hydroxyzine Hydrochloride	Hydroxyzine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-912	Hydroxyzine Hydrochloride	Hydroxyzine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-912	Hydroxyzine Hydrochloride	Hydroxyzine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-912	Hydroxyzine Hydrochloride	Hydroxyzine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-912	Hydroxyzine Hydrochloride	Hydroxyzine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60429-223	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply, Inc.	ANDA	Current
60429-223	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply, Inc.	ANDA	Current
60429-223	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply	ANDA	Current
60429-223	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply	ANDA	Current
60429-224	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply, Inc.	ANDA	Current
60429-224	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply, Inc.	ANDA	Current
60429-224	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply	ANDA	Current
60429-224	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply	ANDA	Current
60429-225	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply, Inc.	ANDA	Current
60429-225	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply, Inc.	ANDA	Current
60429-225	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply	ANDA	Current
60429-225	Hydroxyzine Hydrochloride	Hydroxyzine	Golden State Medical Supply	ANDA	Current
63187-492	Hydroxyzine Hydrochloride	Hydroxyzine	Proficient Rx LP	ANDA	Current
63187-492	Hydroxyzine Hydrochloride	Hydroxyzine	Proficient Rx LP	ANDA	Current
63629-6716	Hydroxyzine Hydrochloride	Hydroxyzine	Bryant Ranch Prepack	ANDA	Current
63629-6716	Hydroxyzine Hydrochloride	Hydroxyzine	Bryant Ranch Prepack	ANDA	Current
65162-575	Hydroxyzine Hydrochloride	Hydroxyzine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-575	Hydroxyzine Hydrochloride	Hydroxyzine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-577	Hydroxyzine Hydrochloride	Hydroxyzine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-577	Hydroxyzine Hydrochloride	Hydroxyzine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-671	Hydroxyzine Hydrochloride	Hydroxyzine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-671	Hydroxyzine Hydrochloride	Hydroxyzine	Amneal Pharmaceuticals LLC	ANDA	Current
67296-1293	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1293	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67405-575	Hydroxyzine Hydrochloride	Hydroxyzine	HARRIS Pharmaceutical, Inc.	ANDA	Current
67405-575	Hydroxyzine Hydrochloride	Hydroxyzine	HARRIS Pharmaceutical, Inc.	ANDA	Current
67405-577	Hydroxyzine Hydrochloride	Hydroxyzine	HARRIS Pharmaceutical, Inc.	ANDA	Current
67405-577	Hydroxyzine Hydrochloride	Hydroxyzine	HARRIS Pharmaceutical, Inc.	ANDA	Current
67405-671	Hydroxyzine Hydrochloride	Hydroxyzine	HARRIS Pharmaceutical, Inc.	ANDA	Current
67405-671	Hydroxyzine Hydrochloride	Hydroxyzine	HARRIS Pharmaceutical, Inc.	ANDA	Current
71335-0986	Hydroxyzine Hydrochloride	Hydroxyzine	Bryant Ranch Prepack	ANDA	Current
71335-0986	Hydroxyzine Hydrochloride	Hydroxyzine	Bryant Ranch Prepack	ANDA	Current