Application 088595

Type: ANDA
Sponsor: DURAMED PHARMS BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	CAPSULE;ORAL	EQ 100MG 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
A088595-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL			1984-02-29

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	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088595-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-02-29	`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 1 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	REMEDYREPACK INC.	0c9101ee-0746-4833-83cf-d0d09e52c0a9	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	561d8abe-97e8-5dc7-e063-6294a90a3923	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	6432d1aa-1e73-469e-835b-43d518963f71	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	2e59dc14-7e17-4663-bc1f-7ee8e104dbfa	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	55012f2c-fa10-2a31-e063-6294a90ae718	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	55033469-f5c6-5180-e063-6394a90af5eb	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	5505ef8f-0322-b705-e063-6394a90a5c5c	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	545f0e87-2688-5381-e063-6394a90a72d4	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Amneal Pharmaceuticals of New York LLC	bc82aaaf-30c7-4afe-a908-d138ea1268ef	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Cardinal Health 107, LLC	6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	509e9a9c-23a3-ade4-e063-6294a90a7403	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	5020c699-6fc5-b166-e063-6294a90a5881	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	PD-Rx Pharmaceuticals, Inc.	98a1c161-5728-4626-a6b0-5414935e4eef	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	8a7084e0-530c-607b-e053-2a95a90a229c	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	a21df116-501f-4818-ad10-ccfa7b03d7ad	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals Inc.	b903f7e1-250d-46d8-a1ec-3f1dabc597f1	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	AvPAK	bff08c15-89b1-00f7-e053-2995a90a2ad8	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	127617c2-9775-3859-e063-6394a90a77cd	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	faf7932b-40ee-8822-e053-6394a90a5e40	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	f99da162-f224-1c19-e053-6294a90acffb	2026-01-01	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.