FDA.reportPublic FDA data

Application 076430

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL5MGNoNo
002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL10MGNoNo
003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL20MGNoNo
004BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0441Benazepril Hydrochloridebenazepril hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0443Benazepril Hydrochloridebenazepril hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0444Benazepril Hydrochloridebenazepril hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0447Benazepril Hydrochloridebenazepril hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
51079-145Benazepril Hydrochloridebenazepril hydrochlorideMylan Institutional Inc.ANDACurrent
51079-146Benazepril Hydrochloridebenazepril hydrochlorideMylan Institutional Inc.ANDACurrent
55154-5672Benazepril Hydrochloridebenazepril hydrochlorideCardinal HealthANDACurrent
55154-5673Benazepril Hydrochloridebenazepril hydrochlorideCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8912ORIG2004-02-27