FDA.reportPublic FDA data

Application 209553

Type
ANDA
Sponsor
YILING PHARM LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo
002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 1GM BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69117-0010ValacyclovirValacyclovirYiling Pharmaceutical, Inc.ANDACurrent
69117-0010ValacyclovirValacyclovirYiling Pharmaceutical, Inc.ANDACurrent
69117-0010ValacyclovirValacyclovirYiling Pharmaceutical, Inc.ANDACurrent
69117-0010ValacyclovirValacyclovirYiling Pharmaceutical, Inc.ANDACurrent
69117-0011ValacyclovirValacyclovir HydrochlorideYiling Pharmaceutical, Inc.ANDACurrent
69117-0011ValacyclovirValacyclovir HydrochlorideYiling Pharmaceutical, Inc.ANDACurrent
69117-0011ValacyclovirValacyclovir HydrochlorideYiling Pharmaceutical, Inc.ANDACurrent
69117-0011ValacyclovirValacyclovir HydrochlorideYiling Pharmaceutical, Inc.ANDACurrent