Application 204226
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 |
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 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2013-09-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204226-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2013-09-09 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|
| 0113-0189 | Good Sense Childrens All Day Allergy | Cetirizine HCl | L. Perrigo Company | ANDA | Current |
| 0113-0189 | Good Sense Childrens All Day Allergy | Cetirizine HCl | L. Perrigo Company | ANDA | Current |
| 0113-0503 | Good Sense Childrens All Day Allergy | Cetirizine HCl | L. Perrigo Company | ANDA | Current |
| 0113-7189 | basic care childrens all day allergy | Cetirizine HCl | L. Perrigo Company | ANDA | Current |
| 0113-7189 | basic care childrens all day allergy | Cetirizine HCl | L. Perrigo Company | ANDA | Current |
| 0113-7475 | basic care childrens all day allergy | Cetirizine HCl | L. Perrigo Company | ANDA | Current |
| 0113-7475 | basic care childrens all day allergy | Cetirizine HCl | L. Perrigo Company | ANDA | Current |
| 0363-0475 | childrens wal zyr | Cetirizine HCl | Walgreen Company | ANDA | Current |
| 0363-0475 | childrens wal zyr | Cetirizine HCl | Walgreen Company | ANDA | Current |
| 0363-0545 | Wal Zyr | Cetirizine HCl | Walgreen Company | ANDA | Current |
| 0363-0545 | Wal Zyr | Cetirizine HCl | Walgreen Company | ANDA | Current |
| 0363-0953 | Childrens Dye Free Wal Zyr | Cetirizine HCl | Walgreen Company | ANDA | Current |
| 0363-0953 | Childrens Dye Free Wal Zyr | Cetirizine HCl | Walgreen Company | ANDA | Current |
| 0363-1475 | childrens dye free wal zyr | Cetirizine HCl | Walgreen Company | ANDA | Current |
| 0363-3311 | childrens allergy relief | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-3393 | childrens allergy relief | Cetirizine Hydrochloride | Walgreen Company | ANDA | Current |
| 0904-6765 | childrens cetirizine hydrochloride | Cetirizine HCl | Major Pharmaceuticals | ANDA | Current |
| 0904-6765 | childrens cetirizine hydrochloride | Cetirizine HCl | Major Pharmaceuticals | ANDA | Current |
| 11673-303 | up and up childrens allergy relief | Cetirizine HCl | Target Corporation | ANDA | Current |
| 11673-303 | up and up childrens allergy relief | Cetirizine HCl | Target Corporation | ANDA | Current |
| 11673-303 | up and up childrens allergy relief | Cetirizine HCl | Target Corporation | ANDA | Current |
| 11673-475 | Up and Up Childrens Allergy Relief | Cetirizine HCl | Target Corporation | ANDA | Current |
| 11822-0475 | childrens allergy relief | Cetirizine HCl | Rite Aid Corporation | ANDA | Current |
| 11822-0475 | childrens allergy relief | Cetirizine HCl | Rite Aid Corporation | ANDA | Current |
| 11822-0475 | childrens allergy relief | Cetirizine HCl | Rite Aid Corporation | ANDA | Current |
| 11822-1189 | childrens allergy relief | Cetirizine HCl | Rite Aid Corporation | ANDA | Current |
| 21130-189 | Signature Care Childrens Allergy Relief | Cetirizine HCl | Safeway | ANDA | Current |
| 21130-475 | Signature Care Childrens Allergy Relief | Cetirizine HCl | Safeway | ANDA | Current |
| 30142-189 | childrens all day allergy | Cetirizine HCl | Kroger Company | ANDA | Current |
| 30142-189 | childrens all day allergy | Cetirizine HCl | Kroger Company | ANDA | Current |
| 30142-475 | Childrens All Day Allergy | Cetirizine HCl | Kroger Company | ANDA | Current |
| 30142-475 | Childrens All Day Allergy | Cetirizine HCl | Kroger Company | ANDA | Current |
| 36800-189 | Topcare Childrens All Day Allergy | Cetirizine HCl | Topco Associates LLC | ANDA | Current |
| 36800-189 | Topcare Childrens All Day Allergy | Cetirizine HCl | Topco Associates LLC | ANDA | Current |
| 36800-475 | TopCare Childrens All Day Allergy | Cetirizine HCl | Topco Associates LLC | ANDA | Current |
| 36800-475 | TopCare Childrens All Day Allergy | Cetirizine HCl | Topco Associates LLC | ANDA | Current |
| 37012-475 | Childrens Allergy Relief | Cetirizine HCl | Shopko Stores Operating Co., LLC | ANDA | Current |
| 41163-475 | Equaline childrens all day allergy | Cetirizine HCl | Supervalu Inc | ANDA | Current |
| 41190-475 | ShopRite Childrens Allergy | Cetirizine HCl | Wakefern Food Corporation | ANDA | Current |
| 41250-189 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-189 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-189 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-475 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-475 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-475 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-475 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-475 | Childrens 24 Hour Allergy | Cetirizine HCl | Meijer Distribution Inc | ANDA | Current |
| 41520-301 | careone childrens allergy relief | Cetirizine HCl | American Sales Company | ANDA | Current |
| 41520-301 | careone childrens allergy relief | Cetirizine HCl | American Sales Company | ANDA | Current |
| 41520-902 | careone childrens allergy relief | Cetirizine HCl | American Sales Company | ANDA | Current |
| 42507-203 | Childrens All Day Allergy | Cetirizine HCl | HyVee Inc | ANDA | Current |
| 42507-475 | childrens all day allergy | Cetirizine HCl | HyVee Inc | ANDA | Current |
| 46122-203 | Good Neighbor Pharmacy Childrens All Day Allergy | Cetirizine HCl | Amerisource Bergen | ANDA | Current |
| 49738-031 | Smart Sense Allergy Relief | Cetirizine HCl | Kmart Corporation | ANDA | Current |
| 49738-189 | Smart Sense Childrens Allergy | Cetirizine HCl | Kmart Corporation | ANDA | Current |
| 49738-475 | smart sense allergy relief | Cetirizine HCl | Kmart Corporation | ANDA | Current |
| 55312-475 | Allergy | Cetirizine HCl | Western Family Foods Inc | ANDA | Current |
| 55316-475 | Healthy Accents Childrens Allergy | Cetirizine HCl | DZA Brands LLC | ANDA | Current |
| 55319-475 | Family Wellness childrens All Day Allergy | Cetirizine HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-901 | family wellness childrens allergy | Cetirizine Hydrochloride | Family Dollar Services Inc | ANDA | Current |
| 55910-475 | rexall all day allergy relief | Cetirizine HCl | Dolgencorp, LLC | ANDA | Current |
| 55910-714 | DG Health Childrens All Day Allergy | Cetirizine HCl | Dolgencorp, LLC | ANDA | Current |
| 55910-714 | DG Health Childrens All Day Allergy | Cetirizine HCl | Dolgencorp, LLC | ANDA | Current |
| 55910-714 | DG Health Childrens All Day Allergy | Cetirizine HCl | Dolgencorp, LLC | ANDA | Current |
| 56062-475 | childrens allergy | Cetirizine HCl | Publix Super Markets Inc | ANDA | Current |
| 59779-509 | Childrens Allergy Relief | Cetirizine HCl | CVS Pharmacy | ANDA | Current |
| 59779-837 | allergy relief | Cetirizine HCl | CVS Pharmacy | ANDA | Current |
| 59779-837 | allergy relief | Cetirizine HCl | CVS Pharmacy | ANDA | Current |
| 62011-0322 | Health Mart childrens all day allergy | Cetirizine HCl | Mckesson | ANDA | Current |
| 62011-0322 | Health Mart childrens all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0322 | Health Mart childrens all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0323 | Health Mart Childrens all day allergy | Cetirizine HCl | Mckesson | ANDA | Current |
| 62011-0323 | Health Mart Childrens all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0323 | Health Mart Childrens all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 63981-475 | Kirkland Signature Childrens Aller Tec | Cetirizine HCl | Costco Wholesale Company | ANDA | Current |
| 64024-475 | Welby Childrens Allergy Relief | Cetirizine Hydrochloride | Aldi Inc | ANDA | Current |
| 68094-004 | Dye Free Childrens Cetirizine Hydrocholride | Cetirizine Hydrochloride | Precision Dose, Inc. | ANDA | Current |
| 68788-8188 | childrens cetirizine hydrochloride | Cetirizine HCl | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69256-475 | Harris Teeter Childrens All Day Allergy | Cetirizine HCl | Harris Teeter, LLC | ANDA | Current |
| 70000-0214 | Leader Childrens All Day Allergy | Cetirizine HCl | Cardinal Health | ANDA | Current |