Application 040805

Type: ANDA
Sponsor: HETERO LABS LTD III

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	TE codes	Approval date
A040805-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29
A040805-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29
A040805-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040805-001	AB
A040805-002	AB
A040805-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040805-002	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040805-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040805-001	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040805-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040805-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040805-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040805-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040805-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040805-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040805-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040805-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040805-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040805-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040805-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040805-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040805-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040805-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040805-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040805-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040805-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040805-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040805-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040805-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040805-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040805-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040805-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040805-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040805-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040805-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040805-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040805-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040805-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040805-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040805-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040805-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040805-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040805-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040805-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040805-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040805-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040805-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040805-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040805-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	f7e527fe-2f67-45ad-a3ec-146ead819514	2022-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040805 application number: ANDA040805 ndc (product): 31722-502 ndc (product): 31722-501 ndc (product): 31722-500

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-500	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-500	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-500	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-501	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-501	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-501	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-502	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-502	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-502	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53885	ORIG	2018-05-01