Application 010485

Type: NDA
Sponsor: ROERIG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATARAX	HYDROXYZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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
N010485-001	ATARAX	HYDROXYZINE HYDROCHLORIDE	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010485-001	ATARAX	10MG/5ML	SYRUP / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010485-001	ATARAX	10MG/5ML	SYRUP / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N010485-001	ATARAX	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982	`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 7 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	2562692e-e9cc-4f81-bdc9-47b7d4233758	2024-04-05	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	f6f688d0-cb13-40af-a65f-480c37334e37	2024-04-03	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Bryant Ranch Prepack	1c7d31fb-5e3c-456e-be6c-a3baafe60c37	2024-04-02	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	c2bce6a4-9feb-4816-a6d8-151e8ef3314d	2024-03-11	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Medsource Pharmaceuticals	13172e1e-2b62-8a67-e063-6394a90a3010	2024-03-07	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3946db7c-dc2d-4329-b9ac-f003d8c6d3e1	2024-01-05	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	e83de74d-b2e0-45c5-b072-170a96216d3a	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	80e60583-76d3-4e65-8581-4cdaff7cd1c1	2023-10-23	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	4590101d-7fb2-478b-acc5-bc9bdbb38ca9	2023-10-11	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d618157e-f43f-4b31-ba5b-8a13a94885bc	2023-09-18	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	2e346b0c-9407-4346-82c2-d9755cbcd8b0	2023-09-11	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	49ee4ecf-b2c0-4301-89da-111e4d853168	2023-09-11	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	46266803-0905-4ae2-9d17-dbf4c2a08181	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3d5d3ebf-e57e-4ed1-be97-d4b299fb738d	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3d2e63c6-993c-42b9-91a0-616246789a7b	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	92d8cc57-7e3a-4217-9160-e1b56db5570e	2023-05-09	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Lannett Company, Inc.	a4fb61ae-aad6-4bd6-83fc-8b227f175df9	2023-01-24	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8e954579-b0f5-4ce3-bade-0b9b972f6f8b	2023-01-23	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	KVK-Tech, Inc.	adc4cb73-77c6-48ff-aaf2-b3568d53de1f	2023-01-04	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	f7e527fe-2f67-45ad-a3ec-146ead819514	2022-11-24	Warnings, Adverse reactions	Name fallback generic name: HYDROXYZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11903	SUPPL	2001-03-21