Application 088488

Type: ANDA
Sponsor: 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 44.

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
A088488-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL			1984-06-15

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A088488-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088488-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088488-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-06-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088488-001	HYDROXYZINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	1984-06-15	`a50c72e98297…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	a21df116-501f-4818-ad10-ccfa7b03d7ad	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088488 application number: ANDA088488 ndc (product): 70518-2769
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Asclemed USA, Inc.	82187031-779e-47bc-943c-eb1a1ef30a7a	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088488 application number: ANDA088488
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	8cf49dda-580a-4263-bd36-f457d0aea922	2023-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088488 application number: ANDA088488 ndc (product): 63629-9244
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Teva Pharmaceuticals USA, Inc.	06068fff-2e79-4721-bcc7-b0938aa20e7a	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088488 application number: ANDA088488 ndc (product): 0555-0324

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0324	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0324	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0324	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0324	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0324	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0324	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
43063-251	Hydroxyzine Pamoate	Hydroxyzine Pamoate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
53808-0431	Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	State of Florida DOH Central Pharmacy	ANDA	Current
63629-9244	Hydroxyzine Pamoate	Hydroxyzine Pamoate	Bryant Ranch Prepack	ANDA	Current
70518-2769	Hydroxyzine Pamoate	Hydroxyzine Pamoate	REMEDYREPACK INC.	ANDA	Current
70518-2769	Hydroxyzine Pamoate	Hydroxyzine Pamoate	REMEDYREPACK INC.	ANDA	Current