Application 204279
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
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 | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204279-001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | |
| A204279-002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | |
| A204279-003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204279-001 | AB |
| A204279-002 | AB |
| A204279-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204279-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204279-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204279-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-001 | AB | 1 | 301d65b070ca… |
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 | Coupler LLC | 5a586fc0-e4e0-5621-e063-6294a90a222b | 2026-08-31 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 583b0ad8-012d-06e5-e063-6294a90a9b12 | 2026-08-04 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Major Pharmaceuticals | 7f76580c-96a0-4b56-8986-ff5488bb9869 | 2026-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | bb4a7d22-2f42-4e9f-bf98-cee43ed14d50 | 2026-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 70518-0487 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc | c8b441bf-a03e-47b3-8f06-c347f5ca4b70 | 2026-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | b6189074-e199-4f58-a78d-c04f131c13d9 | 2026-07-10 | Warnings, Adverse reactions | 204279 ANDA204279 70518-1692 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | 83e8d60d-36fd-4223-b50c-e6615045352a | 2026-07-01 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5506e802-0efc-a845-e063-6394a90aad0e | 2026-06-24 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Incl | 63fdf791-1a58-45ba-8ef2-15b80bb24f23 | 2026-05-11 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 508848a5-017c-dd3e-e063-6294a90a456b | 2026-04-28 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4cd84205-6a33-db48-e063-6394a90a9182 | 2026-04-16 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | 71eea118-395c-4559-aed5-900b635674b8 | 2026-02-12 | Warnings, Adverse reactions | 204279 ANDA204279 70518-2807 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 1350964e-663e-4a50-8c4c-cda371a694a0 | 2026-02-04 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | 4c2c4d8e-c3d1-48c7-8f99-ffa159667465 | 2026-01-19 | Warnings, Adverse reactions | 204279 ANDA204279 70518-1265 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | f2b3d10f-2599-5b71-e053-2a95a90a54bb | 2026-01-01 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | c134195e-a048-530a-e053-2a95a90ad9f8 | 2025-12-26 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | c13455a3-3078-4fe1-e053-2a95a90adf8e | 2025-12-26 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Chartwell RX, LLC | 6533bb4f-efbc-4fca-b625-daa1b3978740 | 2025-12-10 | Warnings, Adverse reactions | 204279 ANDA204279 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Direct Rx | d956063a-ef48-faca-e053-2995a90a0291 | 2025-10-06 | 204279 ANDA204279 72189-333 | |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ca015a35-1f94-4f92-9143-3f149982d316 | 2025-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68788-7858 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0425 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0425 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0425 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0425 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0425 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0425 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0487 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0487 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0487 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0487 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0487 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0488 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0488 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0488 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0488 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0488 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0488 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0488 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1265 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1265 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1692 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1692 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1692 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1692 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2807 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2807 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2807 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-150 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-150 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-150 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-716 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-981 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-541 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-541 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-0268 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0268 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0268 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-333 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Direct Rx | ANDA | Current |