Application 011795
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VISTARIL | HYDROXYZINE PAMOATE | SUSPENSION;ORAL | EQ 25MG HYDROCHLORIDE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011795-001 | VISTARIL | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, Approved before 1982 |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 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N011795-001 | VISTARIL | EQ 25MG HYDROCHLORIDE/5ML | SUSPENSION / 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 pamoate | HYDROXYZINE PAMOATE | Northwind Health Company, LLC | db8987d6-9814-50f6-e053-2a95a90a82a9 | 2026-01-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine pamoate | HYDROXYZINE PAMOATE | Chartwell RX, LLC | abe7280a-1f6a-404b-9874-7710121e2090 | 2025-12-10 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Major Pharmaceuticals | f28f2a1b-8d65-4646-bd99-6e77617f9e1f | 2025-12-10 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | PD-Rx Pharmaceuticals, Inc. | 53153595-41b9-4b2d-8b7d-0ffd29fdd1d8 | 2025-11-05 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Bryant Ranch Prepack | 836ec7f1-e739-4b85-bb52-08d5c5ed4c11 | 2025-11-04 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Bryant Ranch Prepack | 7996dfa3-7f34-4d20-acaa-7f6fc021fc80 | 2025-09-23 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Golden State Medical Supply, Inc. | 240fd428-15af-e7d0-e063-6394a90acbc5 | 2025-08-06 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Bryant Ranch Prepack | 2a869704-2ad0-4ef6-89e6-0f84c39542b6 | 2025-07-29 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 734d32c8-38d3-430f-a2b3-539e03a3687a | 2025-07-08 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Preferred Pharmaceuticals Inc. | 54af47cd-65c2-4bc9-95cd-7883e56ed035 | 2025-06-27 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Preferred Pharmaceuticals, Inc. | 2a66117a-fcd4-4094-927c-3a7699ef9660 | 2025-06-27 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | NuCare Pharmaceuticals,Inc. | aee7c4a8-10cb-2107-e053-2995a90a90e7 | 2025-06-04 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Bryant Ranch Prepack | 34f7e401-9b2c-7d63-e063-6394a90a1f00 | 2025-05-12 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | A-S Medication Solutions | 74bf62c3-b444-46dc-aab6-af74b101a68a | 2025-04-28 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Aphena Pharma Solutions - Tennessee, LLC | 308cd178-a9d2-3132-e063-6394a90a7357 | 2025-04-28 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Asclemed USA, Inc. | 82187031-779e-47bc-943c-eb1a1ef30a7a | 2025-02-17 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Bryant Ranch Prepack | f74e4b3e-992c-402d-92b8-258fccb42b64 | 2025-02-10 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Direct_Rx | fcec985f-9ded-6534-e053-6294a90ac76b | 2025-01-22 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Direct_Rx | 8c395a13-9da3-7b77-e053-2995a90a1916 | 2025-01-22 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | DirectRx | d60603e7-15c5-7b01-e053-2995a90ad252 | 2025-01-21 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.