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HYDROXYZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| ATARAX | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 |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| 2026-08 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | 84e616aacf4f… | ||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| 2026-07 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | caaa826d4ba7… | ||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UTC | 2026-02 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | 011fe1cb6892… | ||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ZIP | 2025-12 | N010485-001 | ATARAX | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | Approved before 1982 | 31067a03dcf5… | ||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 | Advanced Rx of Tennessee, LLC | 09092888-0c18-501d-e063-6294a90aad67 | 2024-12-31 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Asclemed USA, Inc. | 4f3266f4-00a6-4c0c-bff2-e606913de894 | 2024-12-17 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Sunrise Pharmaceutical, Inc. | 94561525-a565-4193-b64d-e1459ab05678 | 2024-12-09 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Chartwell RX, LLC | 934afb42-fee8-415b-8090-2265bb299afe | 2024-10-28 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Chartwell RX, LLC | 53b2d731-f38a-47c0-9e5c-abd3b45e2fe1 | 2024-10-22 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 99995bdb-a35f-7753-e053-2995a90a683c | 2024-10-15 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 79f38cc2-f72f-3f30-e053-2991aa0ac540 | 2024-09-25 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 7b6ebf69-77d5-434f-81a4-3d5587fd431e | 2024-08-29 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 3f5be725-8ade-4889-b6b1-7d45f5458546 | 2024-08-20 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 9714d429-e7f6-4adf-b3f0-cb21e6edb433 | 2024-08-15 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a8af7dd0-fef8-5c39-e053-2a95a90ae11a | 2024-07-17 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1bf88820-e5f9-06e7-e063-6294a90a80ad | 2024-06-28 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 714a26a1-371f-ef23-e053-2a95a90a6af6 | 2024-06-10 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 4b8614d9-335c-4141-aaed-445c604ba08c | 2024-06-10 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | American Regent, Inc. | 8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a | 2024-06-05 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 19b08f92-da63-021f-e063-6394a90a16e2 | 2024-05-30 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 16a63845-6619-293b-e063-6394a90a0a5c | 2024-05-28 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | 138ec5c1-bb06-2a82-e063-6394a90ab42b | 2024-05-17 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | d79be126-39cd-4dbb-ad88-0e4c18109dda | 2024-05-01 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | c59f24b5-0527-423a-ab14-db1ba1f7763f | 2024-04-16 | 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 |