Application 076344

Type
ANDA
Sponsor
SUN PHARM INDS LTD

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
63304-736Benazepril Hydrochloridebenazepril hydrochlorideRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-737Benazepril Hydrochloridebenazepril hydrochlorideRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-738Benazepril Hydrochloridebenazepril hydrochlorideRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-739Benazepril Hydrochloridebenazepril hydrochlorideRanbaxy Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8896ORIG2004-02-12