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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| betr remedies all day allergy relief | CETIRIZINE HYDROCHLORIDE | Live Betr LLC | 4a017852-db01-4085-8947-d92a19ec4e5c | 2023-05-10 | Warnings | 078336 ANDA078336 |
| cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE | Proficient Rx LP | 198ca875-bb8a-49d5-8809-7121ba119381 | 2022-04-01 | Warnings | 078336 ANDA078336 |
| rexall all day allergy relief | CETIRIZINE HYDROCHLORIDE | Dolgencorp, LLC | 4d79fb74-1895-4efe-8016-c0dd5ed10f7a | 2021-06-01 | Warnings | 078336 ANDA078336 |
| basic care all day allergy | CETIRIZINE HYDROCHLORIDE | Amazon.com Services LLC | af8ff570-8f72-4343-b7e1-e977221f5b01 | 2021-04-09 | Warnings | 078336 ANDA078336 |
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 |
|---|---|---|---|---|---|
| 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 |