Application 040812

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040812-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12
A040812-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12
A040812-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040812-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040812-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040812-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-03-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040812-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040812-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040812-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040812-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040812-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040812-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040812-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040812-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040812-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040812-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040812-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040812-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040812-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040812-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040812-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040812-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040812-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040812-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040812-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040812-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040812-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040812-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040812-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040812-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040812-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040812-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040812-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040812-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040812-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040812-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040812-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040812-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040812-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040812-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040812-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040812-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040812-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040812-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040812-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040812-001	AB	1	`6a51e52b5d6a…`

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 8 · 147 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St Mary's Medical Park Pharmacy	9ef6a4b7-362d-61b4-e053-2995a90a0ebb	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	30b6f7b3-b620-961a-e063-6394a90a487b	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	ca67c061-c743-4ebb-a9d5-ece488060663	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	APOZEAL PHARMACEUTICALS INC	87d4bbff-0498-4c26-86cb-7ce173afa0b6	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	be6a2f09-c0f3-44e2-aac3-37e3702b93f0	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: HydrOXYzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Cardinal Health 107, LLC	b4d274ce-d616-4835-80ce-76270524ed36	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7f76580c-96a0-4b56-8986-ff5488bb9869	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	bb4a7d22-2f42-4e9f-bf98-cee43ed14d50	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc	c8b441bf-a03e-47b3-8f06-c347f5ca4b70	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	b6189074-e199-4f58-a78d-c04f131c13d9	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	aa9523e0-c95d-4213-b213-96170d855536	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	5648abce-f20e-717c-e063-6294a90a88ac	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	66be7bde-d2bd-4c65-bde9-0fb9f5be093f	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYZINE HYDROCHLORIDE generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	83e8d60d-36fd-4223-b50c-e6615045352a	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5506e802-0efc-a845-e063-6394a90aad0e	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	American Health Packaging	47bda4fe-ddb7-4140-900a-970373cc7acc	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	f84e3365-57d2-4904-9275-96600f8d74c7	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	9ab23881-334c-474d-9d93-25ea225548dc	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7534a3bb-b4cd-415f-8612-53b37dc6d55f	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2650	hydroxyzine hydrochloride	hydroxyzine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2930	hydroxyzine hydrochloride	hydroxyzine hydrochloride	A-S Medication Solutions	ANDA	Current
53808-0632	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
68462-352	hydroxyzine hydrochloride	hydroxyzine hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-353	hydroxyzine hydrochloride	hydroxyzine hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-354	hydroxyzine hydrochloride	hydroxyzine hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current