Application 077829
- Type
- ANDA
- Sponsor
- UNIQUE PHARM LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | Yes |
| 003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RS | 2009-08-26 | |
| A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2009-08-26 |
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 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Umasuto, LLC | 9af4ab23-d6d3-43f9-a026-76fd9771963f | 2025-03-06 | Warnings | 077829 ANDA077829 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 4b192084-dfdc-47bc-a968-6f49e137b248 | 2024-07-25 | Warnings | 077829 ANDA077829 71335-0300 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Bryant Ranch Prepack | ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7 | 2024-05-21 | Warnings | 077829 ANDA077829 63629-4914 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 6493d4f6-dead-45ec-ade1-28ce624af33d | 2024-02-22 | Warnings | 077829 ANDA077829 16571-401 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Proficient Rx LP | 0b116de8-55c5-44dc-b0b6-f5a919e39a65 | 2019-10-01 | Warnings | 077829 ANDA077829 71205-164 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Proficient Rx LP | 9c2b97d9-9990-46ab-9027-c34ffb07ce8f | 2019-10-01 | Warnings | 077829 ANDA077829 71205-093 |
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 |
|---|---|---|---|---|---|
| 0179-8301 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Kaiser Foundation Hospitals | ANDA | Current |
| 0179-8302 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Kaiser Foundation Hospitals | ANDA | Current |
| 10544-670 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 16571-401 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 16571-401 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-402 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-402 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 33261-393 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-864 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-864 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-864 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 46994-658 | Allergy Relief | Cetirizine Hydrochloride | SAVE-A-LOT FOOD STORES, LTD. | ANDA | Current |
| 46994-658 | Allergy Relief | Cetirizine Hydrochloride | SAVE-A-LOT FOOD STORES, LTD. | ANDA | Current |
| 50090-1089 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1089 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53002-1259 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1259 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-331 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-331 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-429 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-429 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-429 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-538 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | DIRECT RX | ANDA | Current |
| 61919-538 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-538 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-538 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-538 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 63629-4914 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4914 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4914 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8041 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8041 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67296-1085 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | RedPharm Drug | ANDA | Current |
| 67296-1085 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | RedPharm Drug | ANDA | Current |
| 67668-161 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Unique Pharmaceutical Laboratories | ANDA | Current |
| 67668-162 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Unique Pharmaceutical Laboratories | ANDA | Current |
| 68071-1964 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1964 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68210-0450 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-1190 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-1190 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4112 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4112 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4112 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4136 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4136 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4136 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4159 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4159 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4159 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68788-0790 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0790 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0790 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0790 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0790 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0182 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-199 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-199 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-199 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70985-001 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 70985-001 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 70985-001 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 70985-001 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 70985-002 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 70985-002 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 70985-002 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 70985-002 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Drug Ocean LLC | ANDA | Current |
| 71205-093 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-093 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-164 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-164 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-0300 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0300 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |