Application 089146

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 50MG 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
A089146-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG 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	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	1986-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089146-001	HYDROXYZINE PAMOATE	EQ 50MG 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 2 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	Northwind Health Company, LLC	db8987d6-9814-50f6-e053-2a95a90a82a9	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Chartwell RX, LLC	abe7280a-1f6a-404b-9874-7710121e2090	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Major Pharmaceuticals	f28f2a1b-8d65-4646-bd99-6e77617f9e1f	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	PD-Rx Pharmaceuticals, Inc.	53153595-41b9-4b2d-8b7d-0ffd29fdd1d8	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	836ec7f1-e739-4b85-bb52-08d5c5ed4c11	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	7996dfa3-7f34-4d20-acaa-7f6fc021fc80	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Golden State Medical Supply, Inc.	240fd428-15af-e7d0-e063-6394a90acbc5	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	2a869704-2ad0-4ef6-89e6-0f84c39542b6	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	734d32c8-38d3-430f-a2b3-539e03a3687a	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals Inc.	54af47cd-65c2-4bc9-95cd-7883e56ed035	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals, Inc.	2a66117a-fcd4-4094-927c-3a7699ef9660	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	aee7c4a8-10cb-2107-e053-2995a90a90e7	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	34f7e401-9b2c-7d63-e063-6394a90a1f00	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	74bf62c3-b444-46dc-aab6-af74b101a68a	2025-04-28	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	308cd178-a9d2-3132-e063-6394a90a7357	2025-04-28	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Asclemed USA, Inc.	82187031-779e-47bc-943c-eb1a1ef30a7a	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	f74e4b3e-992c-402d-92b8-258fccb42b64	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	fcec985f-9ded-6534-e053-6294a90ac76b	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	8c395a13-9da3-7b77-e053-2995a90a1916	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	DirectRx	d60603e7-15c5-7b01-e053-2995a90ad252	2025-01-21	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.