Application 078199

Type
ANDA
Sponsor
CHARTWELL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-572TERBINAFINETerbinafineChartwell RX, LLCANDACurrent
62135-572TERBINAFINETerbinafineChartwell RX, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9130ORIG2007-07-05