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 4 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	Proficient Rx LP	b7f806ed-da18-41f2-aa0b-bce2336f2756	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	04657694-e8a8-4e52-a179-cfe752819760	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	23561142-45e0-46f5-b17f-d67760b4db27	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Teva Pharmaceuticals USA, Inc.	06068fff-2e79-4721-bcc7-b0938aa20e7a	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Sandoz Inc	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	2022-06-27	Warnings, Adverse reactions	Name fallback brand name: hydroxyzine pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	b098e287-e489-4cdc-9171-7daf50380c1c	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	NCS HealthCare of KY, LLC dba Vangard Labs	207d3478-ac7f-485c-b8ca-e9fcebbdcd89	2022-02-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	d6a1df2e-c111-4ee7-9d56-469db19b7c60	2021-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Pamoate generic name: HYDROXYZINE PAMOATE
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Proficient Rx LP	bff75226-d194-4d64-bcbb-d7d79f5d230e	2021-05-01	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.