Application 078336
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
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 |
| 003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE HIVES | 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 |
|---|---|---|---|---|---|---|---|
| A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-27 | ||
| A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2007-12-27 | ||
| A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-27 | ||
| A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 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 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 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 |
|---|---|---|---|---|---|
| 55301-076 | Exchange select all day allergy | Cetirizine Hydrochloride | Army & Air Force Exchange Service | ANDA | Current |
| 55301-076 | Exchange select all day allergy | Cetirizine Hydrochloride | Army & Air Force Exchange Service | ANDA | Current |
| 55316-458 | healthy accents cetirizine hydrochloride | Cetirizine Hydrochloride | DZA Brands LLC | ANDA | Current |
| 55316-458 | healthy accents cetirizine hydrochloride | Cetirizine Hydrochloride | DZA Brands LLC | ANDA | Current |
| 55316-586 | Healthy Accents allergy relief | Cetirizine Hydrochloride | DZA Brands LLC | ANDA | Current |
| 55316-586 | Healthy Accents allergy relief | Cetirizine Hydrochloride | DZA Brands LLC | ANDA | Current |
| 55910-458 | dg health all day allergy | Cetirizine Hydrochloride | Dolgencorp Inc | ANDA | Current |
| 55910-458 | dg health all day allergy | Cetirizine Hydrochloride | Dolgencorp Inc | ANDA | Current |
| 55910-458 | dg health all day allergy | Cetirizine Hydrochloride | Dolgencorp Inc | ANDA | Current |
| 55910-699 | rexall all day allergy relief | Cetirizine Hydrochloride | Dolgencorp, LLC | ANDA | Current |
| 55910-699 | rexall all day allergy relief | Cetirizine Hydrochloride | Dolgencorp, LLC | ANDA | Current |
| 55910-699 | rexall all day allergy relief | Cetirizine Hydrochloride | Dolgencorp, LLC | ANDA | Current |
| 59779-458 | Allergy Relief | Cetirizine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-458 | Allergy Relief | Cetirizine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-458 | Allergy Relief | Cetirizine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-458 | Allergy Relief | Cetirizine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 63629-3708 | Cetirizine | Cetirizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63940-043 | Core Values Allergy Relief | Cetirizine Hydrochloride | Harmon Stores Inc. | ANDA | Current |
| 63940-043 | Core Values Allergy Relief | Cetirizine Hydrochloride | Harmon Stores Inc. | ANDA | Current |
| 63940-458 | harmon face values allergy relief | Cetirizine Hydrochloride | Harmon Stores Inc. | ANDA | Current |
| 63940-458 | harmon face values allergy relief | Cetirizine Hydrochloride | Harmon Stores Inc. | ANDA | Current |
| 63981-458 | kirkland signature aller tec | Cetirizine Hydrochloride | Costco Wholesale Company | ANDA | Current |
| 63981-458 | kirkland signature aller tec | Cetirizine Hydrochloride | Costco Wholesale Company | ANDA | Current |
| 64024-499 | welby allergy relief | Cetirizine Hydrochloride | Aldi Inc | ANDA | Current |
| 64024-499 | welby allergy relief | Cetirizine Hydrochloride | Aldi Inc | ANDA | Current |
| 64024-499 | welby allergy relief | Cetirizine Hydrochloride | Aldi Inc | ANDA | Current |
| 67046-680 | Cetirizine | Cetirizine | Contract Pharmacy Services-PA | ANDA | Current |
| 68196-458 | Members mark cetirizine | Cetirizine Hydrochloride | Sam's West Inc | ANDA | Current |
| 68196-458 | Members mark cetirizine | Cetirizine Hydrochloride | Sam's West Inc | ANDA | Current |
| 68196-458 | Members mark cetirizine | Cetirizine Hydrochloride | Sam's West Inc | ANDA | Current |
| 68196-502 | members mark aller zyr | Cetirizine Hydrochloride | Sam's West Inc | ANDA | Current |
| 68196-502 | members mark aller zyr | Cetirizine Hydrochloride | Sam's West Inc | ANDA | Current |
| 68391-500 | Berkley and Jensen Allergy Relief | Cetirizine Hydrochloride | BJWC | ANDA | Current |
| 68391-500 | Berkley and Jensen Allergy Relief | Cetirizine Hydrochloride | BJWC | ANDA | Current |
| 68391-500 | Berkley and Jensen Allergy Relief | Cetirizine Hydrochloride | BJWC | ANDA | Current |
| 69256-458 | Harris Teeter All Day Allergy | Cetirizine Hydrochloride | Harris Teeter, LLC | ANDA | Current |
| 70000-0380 | leader all day allergy | Cetirizine Hydrochloride | Cardinal Health | ANDA | Current |
| 70000-0380 | leader all day allergy | Cetirizine Hydrochloride | Cardinal Health | ANDA | Current |
| 70000-0380 | leader all day allergy | Cetirizine Hydrochloride | Cardinal Health | ANDA | Current |
| 70000-0380 | leader all day allergy | Cetirizine Hydrochloride | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70518-1652 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1652 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1652 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1652 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1705 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1705 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1705 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1705 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1705 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2335 | Cetirizine | Cetirizine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70677-0075 | Sunmark All Day Allergy | Cetirizine Hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0075 | Sunmark All Day Allergy | Cetirizine Hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 70925-001 | Humana Pharmacy All Day Allergy | Cetirizine Hydrochloride | Humana Pharmacy, Inc. | ANDA | Current |
| 70925-001 | Humana Pharmacy All Day Allergy | Cetirizine Hydrochloride | Humana Pharmacy, Inc. | ANDA | Current |
| 70934-986 | Cetirizine | Cetirizine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71141-000 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Lidl US LLC | ANDA | Current |
| 71141-000 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Lidl US LLC | ANDA | Current |
| 71205-207 | cetirizine hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-207 | cetirizine hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-207 | cetirizine hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-207 | cetirizine hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-207 | cetirizine hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-207 | cetirizine hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-207 | cetirizine hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71610-123 | Cetirizine | Cetirizine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-123 | Cetirizine | Cetirizine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72288-411 | basic care all day allergy | Cetirizine Hydrochloride | Amazon.com Services LLC | ANDA | Current |
| 72288-411 | basic care all day allergy | Cetirizine Hydrochloride | Amazon.com Services LLC | ANDA | Current |
| 72288-411 | basic care all day allergy | Cetirizine Hydrochloride | Amazon.com Services Inc. | ANDA | Current |
| 80159-101 | picnic antihistamine | Cetirizine Hydrochloride | 30M One, Inc. | ANDA | Current |
| 80267-401 | betr allergy relief | Cetirizine Hydrochloride | Live Betr LLC | ANDA | Current |
| 80267-844 | Betr all day allergy relief | Cetirizine Hydrochloride | Live Betr LLC | ANDA | Current |
| 81522-000 | caring mill all day allergy | Cetirizine Hydrochloride | FSA Store Inc. | ANDA | Current |