Application 010485
- Type
- NDA
- Sponsor
- ROERIG
Application Products#
| 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HYDROXYZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| 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| ATARAX | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | 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| 2026-08 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | 84e616aacf4f… | ||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| 2026-07 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | caaa826d4ba7… | ||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UTC | 2026-02 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | 011fe1cb6892… | ||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ZIP | 2025-12 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | 31067a03dcf5… | ||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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | American Health Packaging | 47bda4fe-ddb7-4140-900a-970373cc7acc | 2026-06-23 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | f84e3365-57d2-4904-9275-96600f8d74c7 | 2026-06-22 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Saptalis Pharmaceuticals, LLC. | 9ab23881-334c-474d-9d93-25ea225548dc | 2026-06-16 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Major Pharmaceuticals | 7534a3bb-b4cd-415f-8612-53b37dc6d55f | 2026-06-15 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 1767a886-ec92-39fb-e063-6294a90a1249 | 2026-06-03 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 534a6a49-23df-d65e-e063-6294a90a1a12 | 2026-06-02 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 52fb8616-7d4e-9c37-e063-6294a90a1112 | 2026-05-29 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 519e54e0-a613-e7b3-e063-6294a90a4452 | 2026-05-12 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 413a39ce-98d6-40f5-9048-ad464e98de44 | 2026-05-11 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 7edd582c-039c-4bdc-bf8a-61eac8a5a9a0 | 2026-05-11 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Incl | 63fdf791-1a58-45ba-8ef2-15b80bb24f23 | 2026-05-11 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | ca843456-0c93-41e8-9bbc-9cd92447f092 | 2026-05-01 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 508848a5-017c-dd3e-e063-6294a90a456b | 2026-04-28 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HydrOXYzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Redpharm Drug | 4fb58637-dc30-c4dd-e063-6394a90a8bbe | 2026-04-18 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4cd84205-6a33-db48-e063-6394a90a9182 | 2026-04-16 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | f6ad4729-b291-42c4-8483-99385d8043db | 2026-04-09 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Kesin Pharma | 4b094d1b-97b2-6ca6-e063-6294a90a2437 | 2026-03-10 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aurobindo Pharma Limited | 9de2de56-614f-4294-8794-d30758cf5f70 | 2026-03-03 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 56b49e5c-bb8a-46cd-873c-3c743d1653a4 | 2026-02-17 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | 71eea118-395c-4559-aed5-900b635674b8 | 2026-02-12 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 11903 | SUPPL | 2001-03-21 |