Application 217652
- Type
- ANDA
- Sponsor
- GRAVITI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217652-001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | |
| A217652-002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | |
| A217652-003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2023-08-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217652-001 | AB |
| A217652-002 | AB |
| A217652-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2023-08-17 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2023-08-17 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2023-08-17 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217652-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2023-08-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217652-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2023-08-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217652-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2023-08-17 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217652-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217652-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217652-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217652-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217652-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217652-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217652-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217652-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217652-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217652-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217652-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217652-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217652-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217652-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217652-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217652-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217652-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217652-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217652-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217652-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217652-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217652-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217652-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217652-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217652-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217652-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217652-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217652-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217652-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217652-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217652-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217652-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217652-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217652-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217652-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217652-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217652-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217652-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217652-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217652-001 | AB | 1 | 8072bd15b7f6… |
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 | St. Mary's Medical Park Pharmacy | 30b6f7b3-b620-961a-e063-6394a90a487b | 2026-07-23 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 5648abce-f20e-717c-e063-6294a90a88ac | 2026-07-10 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 66be7bde-d2bd-4c65-bde9-0fb9f5be093f | 2026-07-02 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 534a6a49-23df-d65e-e063-6294a90a1a12 | 2026-06-02 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 52fb8616-7d4e-9c37-e063-6294a90a1112 | 2026-05-29 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 519e54e0-a613-e7b3-e063-6294a90a4452 | 2026-05-12 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 7edd582c-039c-4bdc-bf8a-61eac8a5a9a0 | 2026-05-11 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | ca843456-0c93-41e8-9bbc-9cd92447f092 | 2026-05-01 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | f6ad4729-b291-42c4-8483-99385d8043db | 2026-04-09 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc | 4aa896b1-4fd5-513e-e063-6294a90ab950 | 2026-02-12 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | afa74394-c079-4ad3-b555-270fe0de3d62 | 2025-12-02 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 69a58bc6-c8a4-48ad-ac77-90fac42e0398 | 2025-12-02 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | a8525244-2acb-4e3e-9769-bbc90549a188 | 2025-12-02 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 87b79b7c-0398-47dc-858d-62e44a1b02f4 | 2025-12-02 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | a9a133e6-efce-4bdb-9335-49c74e57fafe | 2025-11-01 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 2025-08-14 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | 8f41912e-12ce-4174-a0fb-cfb4888d8d58 | 2025-07-16 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 6577589f-1a80-41d8-847a-70c3f38d8dc0 | 2025-06-02 | Warnings, Adverse reactions | 217652 ANDA217652 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a35d1fe2-328d-42ff-ba1f-18a7f2f03c88 | 2025-05-01 | Warnings, Adverse reactions | 217652 ANDA217652 |
| Hydroxyzine HCL | HYDROXYZINE HCL | Direct_rx | 22049012-733e-6b45-e063-6294a90a670f | 2024-09-13 | Warnings, Adverse reactions | 217652 ANDA217652 |