Application 078317
- Type
- ANDA
- Sponsor
- APOTEX INC
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 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 |
|---|---|---|---|---|---|---|---|
| A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-27 | ||
| A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2007-12-27 |
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 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078317-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078317-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | CETIRIZINE HCL 10 MG | Allegiant Health | 96952314-fd4c-455f-b55e-645c19d6e366 | 2018-12-31 | Warnings | 078317 ANDA078317 69168-392 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-1024 | Wal-Zyr | Wal-Zyr | Walgreen Company | ANDA | Current |
| 0363-1024 | Wal-Zyr | Wal-Zyr | Walgreen Company | ANDA | Current |
| 0536-1041 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Rugby Laboratories | ANDA | Current |
| 0536-1041 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Rugby Laboratories | ANDA | Current |
| 0904-5852 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Major Pharmaceuticals | ANDA | Current |
| 0904-5852 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Major Pharmaceuticals | ANDA | Current |
| 0904-5852 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-5852 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 11822-6053 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Rite Aid Corporation | ANDA | Current |
| 11822-6053 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Rite Aid Corporation | ANDA | Current |
| 11822-6059 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Rite Aid Corporation | ANDA | Current |
| 11822-6059 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Rite Aid Corporation | ANDA | Current |
| 11822-7053 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Rite Aid Corporation | ANDA | Current |
| 11822-7053 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Rite Aid Corporation | ANDA | Current |
| 33992-3962 | Allergy Relief | Cetirizine HCl 10 mg | Greenbrier International | ANDA | Current |
| 50066-310 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50066-310 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50066-396 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50066-396 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50090-3188 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3188 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 60505-2632 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2632 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2633 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2633 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-4650 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Apotex Corp. | ANDA | Current |
| 60505-4650 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Apotex Corp. | ANDA | Current |
| 60687-165 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | American Health Packaging | ANDA | Current |
| 63187-932 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-932 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-5153 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5153 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68071-1988 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1988 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 69168-310 | Allergy Relief | Cetirizine HCl 10 mg | Allegiant Health | ANDA | Current |
| 69168-310 | Allergy Relief | Cetirizine HCl 10 mg | Allegiant Health | ANDA | Current |
| 69168-392 | Allergy Relief | Cetirizine HCl 10 mg | Allegiant Health | ANDA | Current |
| 70518-0910 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0910 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1989 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1989 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1989 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0755 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0755 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-048 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-093 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |