Application 087862

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

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

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
A087862-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL			1983-04-18

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087862-001	HYDROXYZINE HYDROCHLORIDE	100MG	TABLET / ORAL	1983-04-18	`f41ea6bd6efb…`

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 4 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	a9a133e6-efce-4bdb-9335-49c74e57fafe	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Henry Schein, Inc.	7279ad5a-0a49-432d-8fa2-17e4c6ecbadc	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7165a30c-09e4-4ca1-8548-bf71998ba12f	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4789b7ae-314c-43c0-ad33-92ff50085f27	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	24cb9c83-a7e4-4bae-997c-c3a87426f78c	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	263d3f22-a105-4abb-8152-be2081eefcde	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	cc6a12ed-411b-4b0c-8108-58ef7db8da55	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	eef36dab-c318-44d2-8583-7bae3bfceee7	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Direct Rx	d956063a-ef48-faca-e053-2995a90a0291	2025-10-06		Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	fc148d96-b868-4e45-b7d2-977faf431049	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	93d117dd-e2bf-4daa-abe3-d4fefed3313c	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	3f90259a-a684-498f-8963-d02eaba2e9db	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	9c2c05e0-b123-4ddf-8b07-6bb3ca0678b5	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b05bd0e-af57-4e74-92f8-a4311330142f	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	214b3f14-2f6c-4f36-b7a6-e0b1f820e3a7	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6a1a48ac-8ad5-4363-b298-d9825ae2a448	2025-08-14	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	80309ec1-e5d5-4454-b8ce-67d7e6805e44	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE ORAL	Bionpharma Inc.	39f93633-000e-6c3f-e063-6394a90a5a0b	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ca015a35-1f94-4f92-9143-3f149982d316	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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