Application 087014
- Type
- ANDA
- Sponsor
- ORGANON USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | No | No |
| 002 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087014-001 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A087014-002 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 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 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A087014-001 | ORGATRAX | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A087014-002 | ORGATRAX | 50MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… |
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 | Golden State Medical Supply, Inc. | 2fc9b08a-e675-dbc5-e063-6294a90ad054 | 2025-07-02 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2 | 2025-06-27 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 44c63e67-a9e0-4a4f-b34e-2ca60a981766 | 2025-06-20 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 6577589f-1a80-41d8-847a-70c3f38d8dc0 | 2025-06-02 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 2a343906-0bea-4bd8-bd35-c3f199d9b266 | 2025-05-30 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | e4e6a91d-f10b-4d85-a526-4c6192ea85dc | 2025-05-23 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | a8c83479-f919-49f9-b125-747bd0e3211c | 2025-05-23 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 7c959515-a5a9-4d5e-90e9-bd58bc947330 | 2025-05-23 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f9ff4b7c-dc81-47af-8371-5c681eb0d876 | 2025-05-16 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | b52e1759-8be3-4e46-a891-4eaa9270c421 | 2025-05-15 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP. | a2fbc502-6ca3-4304-9069-b7249c9d9489 | 2025-05-12 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a35d1fe2-328d-42ff-ba1f-18a7f2f03c88 | 2025-05-01 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 5ff091be-6e30-4305-a172-769ee45e110b | 2025-04-02 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | dd9e5dc5-720c-4de8-abae-6404c31f341f | 2025-03-31 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | d03fdfd0-5dbd-40fe-a6e3-082a47751c2c | 2025-03-31 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 0c687cbe-ce40-4bc0-b880-5166b5be7a80 | 2025-03-20 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | 31a907e6-7fae-0682-e063-6294a90a24a5 | 2025-03-01 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 43889411-a303-41a1-b03b-1ee46f452c54 | 2025-02-11 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| HydrOXYzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ffd33207-3f35-3486-e053-6394a90ac0ae | 2025-02-05 | Warnings, Adverse reactions | HYDROXYZINE HYDROCHLORIDE |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Epic Pharma, LLC | 82b015dc-999c-46a4-bcaa-a4c81a193b68 | 2025-01-31 | 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 |
|---|---|---|
| 53922 | ORIG | 2018-05-01 |