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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | d06236e962d9… |
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.
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 |