Application 010392
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010392-001 | ATARAX | HYDROXYZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N010392-004 | ATARAX | HYDROXYZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N010392-005 | ATARAX | HYDROXYZINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N010392-006 | ATARAX | HYDROXYZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N010392-001 | ATARAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N010392-004 | ATARAX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N010392-005 | ATARAX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N010392-006 | ATARAX | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N010392-001 | ATARAX | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N010392-004 | ATARAX | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N010392-005 | ATARAX | 100MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N010392-006 | ATARAX | 50MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N010392-001 | ATARAX | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N010392-004 | ATARAX | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N010392-005 | ATARAX | 100MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N010392-006 | ATARAX | 50MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… |
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 | REMEDYREPACK INC. | 58d99cf6-2319-410b-b8be-de9c304541b6 | 2026-09-08 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 5a586fc0-e4e0-5621-e063-6294a90a222b | 2026-08-31 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | 8f41912e-12ce-4174-a0fb-cfb4888d8d58 | 2026-08-27 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 583b0ad8-012d-06e5-e063-6294a90a9b12 | 2026-08-04 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | St Mary's Medical Park Pharmacy | 9ef6a4b7-362d-61b4-e053-2995a90a0ebb | 2026-07-28 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HydrOXYzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca | 2026-07-24 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 30b6f7b3-b620-961a-e063-6394a90a487b | 2026-07-23 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | APOZEAL PHARMACEUTICALS INC | 87d4bbff-0498-4c26-86cb-7ce173afa0b6 | 2026-07-21 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HydrOXYzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | be6a2f09-c0f3-44e2-aac3-37e3702b93f0 | 2026-07-21 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Cardinal Health 107, LLC | b4d274ce-d616-4835-80ce-76270524ed36 | 2026-07-20 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Major Pharmaceuticals | 7f76580c-96a0-4b56-8986-ff5488bb9869 | 2026-07-15 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | bb4a7d22-2f42-4e9f-bf98-cee43ed14d50 | 2026-07-15 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc | c8b441bf-a03e-47b3-8f06-c347f5ca4b70 | 2026-07-15 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | b6189074-e199-4f58-a78d-c04f131c13d9 | 2026-07-10 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 5648abce-f20e-717c-e063-6294a90a88ac | 2026-07-10 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 66be7bde-d2bd-4c65-bde9-0fb9f5be093f | 2026-07-02 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | 83e8d60d-36fd-4223-b50c-e6615045352a | 2026-07-01 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5506e802-0efc-a845-e063-6394a90aad0e | 2026-06-24 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 218 | SUPPL | 2001-03-21 |