Application 040156
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 25MG HYDROCHLORIDE | No | No |
| 002 | HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 50MG HYDROCHLORIDE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040156-001 | HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | |
| A040156-002 | HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040156-001 | AB |
| A040156-002 | 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 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040156-001 | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040156-002 | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | 1996-07-15 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A040156-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040156-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040156-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040156-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040156-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040156-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040156-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040156-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040156-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040156-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040156-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040156-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040156-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040156-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040156-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040156-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040156-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040156-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040156-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040156-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040156-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A040156-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040156-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A040156-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040156-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040156-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040156-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040156-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040156-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040156-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040156-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040156-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040156-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A040156-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040156-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A040156-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040156-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040156-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040156-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A040156-002 | AB | 1 | 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 | Amneal Pharmaceuticals of New York LLC | bc82aaaf-30c7-4afe-a908-d138ea1268ef | 2026-06-11 | Warnings, Adverse reactions | 040156 ANDA040156 0115-1804 0115-1803 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | AvPAK | bff08c15-89b1-00f7-e053-2995a90a2ad8 | 2026-01-08 | Warnings, Adverse reactions | 040156 ANDA040156 50268-399 50268-398 |
| HYDROXYZINE PAMOATE | HYDROXYZINE PAMOATE | DirectRx | d60603e7-15c5-7b01-e053-2995a90ad252 | 2025-01-21 | Warnings, Adverse reactions | 040156 ANDA040156 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | NuCare Pharmaceuticals,Inc. | 8a8416f8-18ce-99e6-e053-2995a90a1045 | 2024-06-14 | Warnings, Adverse reactions | 040156 ANDA040156 68071-4915 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Bryant Ranch Prepack | 4ea3336a-2cc8-4e43-bc55-455fca67976e | 2023-11-27 | Warnings, Adverse reactions | 040156 ANDA040156 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | A-S Medication Solutions | 42186eab-89d1-4963-bfd8-087b3024af33 | 2023-11-08 | Warnings, Adverse reactions | 040156 ANDA040156 50090-4579 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Bryant Ranch Prepack | f24c19d4-fd3e-4ed3-aeb7-7bc5e0dd0244 | 2023-08-10 | Warnings, Adverse reactions | 040156 ANDA040156 71335-0998 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Proficient Rx LP | 04657694-e8a8-4e52-a179-cfe752819760 | 2022-11-01 | Warnings, Adverse reactions | 040156 ANDA040156 71205-087 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Proficient Rx LP | 23561142-45e0-46f5-b17f-d67760b4db27 | 2022-11-01 | Warnings, Adverse reactions | 040156 ANDA040156 71205-123 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | NCS HealthCare of KY, LLC dba Vangard Labs | 207d3478-ac7f-485c-b8ca-e9fcebbdcd89 | 2022-02-10 | Warnings, Adverse reactions | 040156 ANDA040156 0615-8420 0615-8419 |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Aphena Pharma Solutions - Tennessee, LLC | d6a1df2e-c111-4ee7-9d56-469db19b7c60 | 2021-10-15 | Warnings, Adverse reactions | 040156 ANDA040156 |
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 |
|---|---|---|---|---|---|
| 0115-1670 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1670 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Impax Generics | ANDA | Current |
| 0115-1671 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1671 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Impax Generics | ANDA | Current |
| 0115-1803 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Impax Generics | ANDA | Current |
| 0115-1803 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1803 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1803 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1803 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1803 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1804 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Impax Generics | ANDA | Current |
| 0115-1804 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1804 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1804 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1804 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1804 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0615-8419 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8420 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 10544-556 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-573 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Rebel Distributors Corp | ANDA | Current |
| 42291-322 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvKARE, Inc. | ANDA | Current |
| 42291-323 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvKARE, Inc. | ANDA | Current |
| 42291-406 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvKARE, Inc. | ANDA | Current |
| 42291-406 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvKARE | ANDA | Current |
| 42291-407 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvKARE, Inc. | ANDA | Current |
| 42291-407 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvKARE | ANDA | Current |
| 43353-199 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-4471 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | A-S Medication Solutions | ANDA | Current |
| 50090-4471 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | A-S Medication Solutions | ANDA | Current |
| 50090-4579 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | A-S Medication Solutions | ANDA | Current |
| 50090-4579 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | A-S Medication Solutions | ANDA | Current |
| 50268-398 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvPAK | ANDA | Current |
| 50268-398 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvPAK | ANDA | Current |
| 50268-398 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvPAK | ANDA | Current |
| 50268-399 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvPAK | ANDA | Current |
| 50268-399 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvPAK | ANDA | Current |
| 50268-399 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | AvPAK | ANDA | Current |
| 53808-0426 | Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0429 | Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-860 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Quality Care Products, LLC | ANDA | Current |
| 55700-860 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Quality Care Products, LLC | ANDA | Current |
| 55700-860 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Quality Care Products, LLC | ANDA | Current |
| 55700-860 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Quality Care Products, LLC | ANDA | Current |
| 55700-860 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Quality Care Products, LLC | ANDA | Current |
| 55700-860 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Quality Care Products, LLC | ANDA | Current |
| 63187-034 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 63187-034 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 63629-5415 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Bryant Ranch Prepack | ANDA | Current |
| 64725-0800 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | TYA Pharmaceuticals | ANDA | Current |
| 64725-0801 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | TYA Pharmaceuticals | ANDA | Current |
| 67046-283 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1660 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1660 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1660 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2573 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4509 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4915 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4915 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7280 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7280 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7280 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7564 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7564 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7564 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0883 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1411 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1411 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1411 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1411 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3194 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | REMEDYREPACK INC. | ANDA | Current |
| 70934-444 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-087 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 71205-087 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 71205-087 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 71205-123 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 71205-123 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 71205-123 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 71205-123 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Proficient Rx LP | ANDA | Current |
| 71335-0998 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0998 | Hydroxyzine Pamoate | Hydroxyzine Pamoate | Bryant Ranch Prepack | ANDA | Current |