FDA.reportPublic FDA data

Application 202438

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMCICLOVIRFAMCICLOVIRTABLET;ORAL125MGNoNo
002FAMCICLOVIRFAMCICLOVIRTABLET;ORAL250MGNoNo
003FAMCICLOVIRFAMCICLOVIRTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0705FamciclovirFamciclovirATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0706FamciclovirFamciclovirATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0708FamciclovirFamciclovirATLANTIC BIOLOGICALS CORP.ANDACurrent
31722-706FamciclovirFamciclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-706FamciclovirFamciclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-707FamciclovirFamciclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-707FamciclovirFamciclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-708FamciclovirFamciclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-708FamciclovirFamciclovirCamber Pharmaceuticals, Inc.ANDACurrent
50090-3337FamciclovirFamciclovirA-S Medication SolutionsANDACurrent
63187-998FamciclovirFamciclovirProficient Rx LPANDACurrent
63187-998FamciclovirFamciclovirProficient Rx LPANDACurrent
63187-998FamciclovirFamciclovirProficient Rx LPANDACurrent
63629-7890FamciclovirFamciclovirBryant Ranch PrepackANDACurrent
63629-7890FamciclovirFamciclovirBryant Ranch PrepackANDACurrent