Home Applications 201546 Application 201546
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE SYRUP;ORAL 5MG/5ML No No 002 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE SYRUP;ORAL 5MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201546-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2011-05-20 A201546-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2011-05-20
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.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A201546-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2011-05-20 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A201546-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2011-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201546-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2011-05-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 A201546-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2011-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201546-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2011-05-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201546-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SYRUP / ORAL 2011-05-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201546-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2011-05-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201546-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2011-05-20 a50c72e98297…
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.
Matched openFDA labels page 1 of 1 · 8 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 26 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-2106 Wal-Zyr Cetirizine Hydrochloride WALGREEN COMPANY ANDA Current 11673-106 up and up Cetirizine Hydrochloride Target Corporation ANDA Current 11822-2106 Rite Aid Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 11822-2106 Rite Aid Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 11822-2106 Rite Aid Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 21130-106 Safeway Cetirizine Hydrochloride Safeway Inc. ANDA Current 30142-106 Childrens Cetirizine Hydrochloride Kroger Company ANDA Current 37205-591 Leader Childrens Allergy Relief Cetirizine Hydrochloride Cardinal Health ANDA Current 37808-106 Allergy Relief Cetirizine Hydrochloride H E B ANDA Current 41250-106 Childrens Cetirizine Hydrochloride Meijer Distribution Inc ANDA Current 46122-101 All Day Cetirizine Hydrochloride Amerisource Bergen ANDA Current 46122-101 All Day Cetirizine Hydrochloride Amerisource Bergen ANDA Current 49035-106 Childrens Cetirizine Hydrochloride Wal-Mart Stores Inc ANDA Current 49348-078 Childrens Cetirizine Hydrochloride McKesson ANDA Current 51672-2106 Cetirizine Hydrochloride Cetirizine Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2106 Cetirizine Hydrochloride Cetirizine Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2148 CHILDRENS CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride TARO PHARMACEUTICALS U.S.A., INC. ANDA Current 52549-2106 Cetirizine Hydrochloride Cetirizine Hydrochloride Taro Pharmaceutical Industries, Ltd. ANDA Current 55312-106 Western Family Cetirizine Hydrochloride Western Family Foods Inc ANDA Current 56062-106 Childrens Allergy Cetirizine Hydrochloride Publix Super Markets Inc ANDA Current 56062-106 Childrens Allergy Cetirizine Hydrochloride Publix Super Markets Inc ANDA Current 59779-106 CVS Cetirizine Hydrochloride CVS Pharmacy ANDA Current 62011-0093 Childrens Cetirizine Hydrochloride Cetirizine hydrochloride Health Mart ANDA Current 63868-106 Quality Choice Cetirizine Hydrochloride Chain Drug Marketing Association ANDA Current 68016-106 Childrens Cetirizine Hydrochloride Pharmacy Value Alliance LLC ANDA Current 70253-106 Our Family Cetirizine Hydrochloride Nash Finch Company ANDA Current