Application 077555

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDETABLET;ORAL2MGNoNo
002TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDETABLET;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62756-200TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
62756-224TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9058ORIG2011-11-10