FDA.reportPublic FDA data

Application 076677

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3635Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3635Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3635Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3635Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3637Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3637Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3637Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3637Cetirizine Hydrochloridecetirizine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
12634-987CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEApotheca Inc.ANDACurrent
51079-597Cetirizine Hydrochloridecetirizine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-597Cetirizine Hydrochloridecetirizine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-597Cetirizine Hydrochloridecetirizine hydrochlorideMylan Institutional Inc.ANDACurrent
55154-5399Cetirizine Hydrochloridecetirizine hydrochlorideCardinal HealthANDACurrent
55154-5399Cetirizine Hydrochloridecetirizine hydrochlorideCardinal HealthANDACurrent
55154-5399Cetirizine Hydrochloridecetirizine hydrochlorideCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8946ORIG2008-01-09
18450ORIG2008-01-08