FDA.reportPublic FDA data

Application 022155

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S ZYRTEC HIVES RELIEFCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLYesYes
002CHILDREN'S ZYRTEC ALLERGYCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16853-1261ALLEROFFCetirizine HydrochlorideCorporacion InfarmasaNDACurrent
50580-721Childrens Zyrtec AllergyCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-721Childrens Zyrtec AllergyCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-730Childrens ZyrtecCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-730Childrens ZyrtecCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-730Childrens ZyrtecCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-730Childrens ZyrtecCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84608SUPPL 2025-12-31
84605SUPPL 2025-12-31
80887SUPPL 2025-01-21
80214SUPPL 2025-01-21
80446SUPPL 2024-11-29
80445SUPPL 2024-11-29
55943SUPPL2018-10-15
55925SUPPL2018-10-15
38315SUPPL2016-04-20
6980SUPPL2016-04-18
6979SUPPL2014-05-20
17027SUPPL2014-05-19
29332SUPPL2012-05-24
6978SUPPL2009-03-17
6977SUPPL2009-03-05
6976SUPPL2008-08-19
6975SUPPL2008-08-19
42432ORIG2008-05-21
6974ORIG2007-11-26