Application 089145

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	CAPSULE;ORAL	EQ 25MG HYDROCHLORIDE	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
A089145-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL			1986-03-17

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	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089145-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	02616eee-a1a4-4afc-b84e-69fd28755138	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceutcals, Inc.	2879c79f-bf2f-0bc9-e063-6394a90a98ae	2024-12-04	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	American Health Packaging	e1a7d95c-e6f6-4a89-90b0-002156e90b41	2024-11-21	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	a31271f0-ac60-4fda-b1f5-ddf7241c8a0e	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	fac2df9d-d395-4b07-b299-2ed946441b22	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8cb94f1d-1e45-531a-e053-2a95a90a1ba0	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8a8416f8-18ce-99e6-e053-2995a90a1045	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Pharmasource Meds, LLC	f563aa1a-1e21-49d4-e053-2a95a90a3264	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	dde576e9-fb6b-40d2-a81f-ebb8656c4c9c	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	1302c511-eb25-5818-e063-6394a90a9225	2024-03-06	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	1136a291-2f2f-c025-e063-6294a90a76d7	2024-02-12	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	78005ad7-290c-4716-937f-f0ec82f4e607	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	dd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b	2024-01-21	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	4ea3336a-2cc8-4e43-bc55-455fca67976e	2023-11-27	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0	2023-11-27	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	c29f005e-ae75-415d-9fd6-591f074dcda5	2023-11-15	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	42186eab-89d1-4963-bfd8-087b3024af33	2023-11-08	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	ea1c7326-52ea-4934-844c-892d868042cf	2023-10-25	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	f24c19d4-fd3e-4ed3-aeb7-7bc5e0dd0244	2023-08-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	8cf49dda-580a-4263-bd36-f457d0aea922	2023-03-28	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE

Reported adverse events (FAERS/openFDA)#

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