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| HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| ATARAX | HYDROXYZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| ATARAX | HYDROXYZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| ATARAX | HYDROXYZINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| ATARAX | HYDROXYZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | 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 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | 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 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | 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 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | 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 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | 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 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | 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 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | 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 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | 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 | 2680178bc6a6… | ||
| 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… |
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 |
|---|---|---|
| 218 | SUPPL | 2001-03-21 |