FDA.reportPublic FDA data

Application 091114

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
57237-194FamciclovirFamciclovirCitron Pharma LLCANDACurrent
57237-195FamciclovirFamciclovirCitron Pharma LLCANDACurrent
57237-196FamciclovirFamciclovirCitron Pharma LLCANDACurrent
64980-349FamciclovirFamciclovirRising Pharmaceuticals, Inc.ANDACurrent
64980-349FamciclovirFamciclovirRising Pharmaceuticals, Inc.ANDACurrent
64980-350FamciclovirFamciclovirRising Pharmaceuticals, Inc.ANDACurrent
64980-350FamciclovirFamciclovirRising Pharmaceuticals, Inc.ANDACurrent
64980-351FamciclovirFamciclovirRising Pharmaceuticals, Inc.ANDACurrent
64980-351FamciclovirFamciclovirRising Pharmaceuticals, Inc.ANDACurrent
65862-465FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-465FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-465FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-465FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-466FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-466FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-466FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-466FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-467FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-467FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-467FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent
65862-467FamciclovirFamciclovirAurobindo Pharma LimitedANDACurrent