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 |
|---|---|---|---|---|---|
| 0113-7002 | Basic Care All Day Allergy | Cetirizine Hydrochloride | L. Perrigo Company | ANDA | Current |
| 0113-7002 | Basic Care All Day Allergy | Cetirizine Hydrochloride | L. Perrigo Company | ANDA | Current |
| 0113-9458 | Good Sense all day allergy | Cetirizine Hydrochloride | L Perrigo Company | ANDA | Current |
| 0113-9458 | Good Sense all day allergy | Cetirizine Hydrochloride | L Perrigo Company | ANDA | Current |
| 0113-9458 | Good Sense all day allergy | Cetirizine Hydrochloride | L Perrigo Company | ANDA | Current |
| 0113-9458 | Good Sense all day allergy | Cetirizine Hydrochloride | L. Perrigo Company | ANDA | Current |
| 0363-0495 | Wal Zyr | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-0495 | Wal Zyr | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-0495 | Wal Zyr | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-4101 | allergy relief | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-4101 | allergy relief | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-4101 | allergy relief | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0615-8240 | cetirizine hydrochloride | Cetirizine Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8240 | cetirizine hydrochloride | Cetirizine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6717 | Cetirizine | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6717 | Cetirizine | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6717 | Cetirizine | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6717 | Cetirizine | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6717 | Cetirizine | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6717 | Cetirizine | Cetirizine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 10202-458 | 7 select all day allergy | Cetirizine Hydrochloride | 7-Eleven | ANDA | Current |
| 10202-458 | 7 select all day allergy | Cetirizine Hydrochloride | 7-Eleven | ANDA | Current |
| 11673-502 | Up and Up Allergy Relief | Cetirizine Hydrochloride | Target Corporation | ANDA | Current |
| 11673-502 | Up and Up Allergy Relief | Cetirizine Hydrochloride | Target Corporation | ANDA | Current |
| 11673-502 | Up and Up Allergy Relief | Cetirizine Hydrochloride | Target Corporation | ANDA | Current |
| 11822-0458 | allergy relief | Cetirizine Hydrochloride | Rite Aid Corporation | ANDA | Current |
| 11822-0458 | allergy relief | Cetirizine Hydrochloride | Rite Aid Corporation | ANDA | Current |
| 11822-0458 | allergy relief | Cetirizine Hydrochloride | Rite Aid Corporation | ANDA | Current |
| 11822-1002 | all day allergy | Cetirizine Hydrochloride | Rite Aid Corporation | ANDA | Current |
| 11822-1002 | all day allergy | Cetirizine Hydrochloride | Rite Aid Corporation | ANDA | Current |
| 21130-090 | signature care allergy relief | Cetirizine Hydrochloride | Safeway | ANDA | Current |
| 21130-090 | signature care allergy relief | Cetirizine Hydrochloride | Safeway | ANDA | Current |
| 21130-090 | signature care allergy relief | Cetirizine Hydrochloride | Safeway | ANDA | Current |
| 21130-090 | signature care allergy relief | Cetirizine Hydrochloride | Safeway | ANDA | Current |
| 24385-998 | good neighbor pharmacy all day allergy | Cetirizine Hydrochloride | Amerisource Bergen | ANDA | Current |
| 24385-998 | good neighbor pharmacy all day allergy | Cetirizine Hydrochloride | Amerisource Bergen | ANDA | Current |
| 30142-458 | All Day Allergy | Cetirizine Hydrochloride | Kroger Company | ANDA | Current |
| 30142-458 | All Day Allergy | Cetirizine Hydrochloride | Kroger Company | ANDA | Current |
| 30142-458 | All Day Allergy | Cetirizine Hydrochloride | Kroger Company | ANDA | Current |
| 36800-458 | TopCare All Day Allergy | Cetirizine Hydrochloride | Topco Associates LLC | ANDA | Current |
| 36800-458 | TopCare All Day Allergy | Cetirizine Hydrochloride | Topco Associates LLC | ANDA | Current |
| 37012-458 | Allergy Relief | Cetirizine Hydrochloride | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-458 | Allergy Relief | Cetirizine Hydrochloride | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37808-458 | Rx Act all day allergy relief | Cetirizine Hydrochloride | H E B | ANDA | Current |
| 37808-550 | all day allergy relief | Cetirizine Hydrochloride | H E B | ANDA | Current |
| 37808-583 | allergy relief | Cetirizine Hydrochloride | H E B | ANDA | Current |
| 37808-583 | allergy relief | Cetirizine Hydrochloride | H E B | ANDA | Current |
| 37808-583 | allergy relief | Cetirizine Hydrochloride | H E B | ANDA | Current |
| 41163-458 | Equaline all day allergy | Cetirizine Hydrochloride | Supervalu Inc | ANDA | Current |
| 41163-458 | Equaline all day allergy | Cetirizine Hydrochloride | Supervalu Inc | ANDA | Current |
| 41163-458 | Equaline all day allergy | Cetirizine Hydrochloride | Supervalu Inc | ANDA | Current |
| 41163-458 | Equaline all day allergy | Cetirizine Hydrochloride | Supervalu Inc | ANDA | Current |
| 41190-458 | ShopRite Allergy | Cetirizine Hydrochloride | Wakefern Food Corporation | ANDA | Current |
| 41190-458 | ShopRite Allergy | Cetirizine Hydrochloride | Wakefern Food Corporation | ANDA | Current |
| 41250-458 | 24 hour allergy | Cetirizine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-458 | 24 hour allergy | Cetirizine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-458 | 24 hour allergy | Cetirizine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-458 | 24 hour allergy | Cetirizine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-721 | allergy relief | Cetirizine Hydrochloride | Meijer, Inc. | ANDA | Current |
| 41250-721 | allergy relief | Cetirizine Hydrochloride | Meijer, Inc. | ANDA | Current |
| 41520-781 | CareOne Allergy Relief | Cetirizine Hydrochloride | American Sales Company | ANDA | Current |
| 41520-781 | CareOne Allergy Relief | Cetirizine Hydrochloride | American Sales Company | ANDA | Current |
| 41520-781 | CareOne Allergy Relief | Cetirizine Hydrochloride | American Sales Company | ANDA | Current |
| 45802-919 | cetirizine hydrochloride | Cetirizine Hydrochloride | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-919 | cetirizine hydrochloride | Cetirizine Hydrochloride | Perrigo New York Inc | ANDA | Current |
| 45802-919 | cetirizine hydrochloride | Cetirizine Hydrochloride | Perrigo New York Inc | ANDA | Current |
| 49035-458 | equate allergy relief | Cetirizine Hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49035-458 | equate allergy relief | Cetirizine Hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49035-458 | equate allergy relief | Cetirizine Hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49738-600 | smart sense allergy relief | Cetirizine Hydrochloride | Kmart Corporation | ANDA | Current |
| 50090-4344 | cetirizine hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4358 | cetirizine hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5510 | Cetirizine | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5510 | Cetirizine | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50594-006 | sound body all day allergy | Cetirizine Hydrochloride | Big Lots Stores, Inc. | ANDA | Current |
| 50594-006 | sound body all day allergy | Cetirizine Hydrochloride | Big Lots Stores, Inc. | ANDA | Current |
| 50594-006 | sound body all day allergy | Cetirizine Hydrochloride | Big Lots Stores, Inc. | ANDA | Current |
| 55154-8081 | Cetirizine | Cetirizine Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8081 | Cetirizine | Cetirizine Hydrochloride | Cardinal Health | ANDA | Current |
| 55301-076 | Exchange select all day allergy | Cetirizine Hydrochloride | Army & Air Force Exchange Service | ANDA | Current |