FDA.reportPublic FDA data

Application 078278

Type
ANDA
Sponsor
CIPLA

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
16714-614FamciclovirFamciclovirNorthStar RxLLCANDACurrent
16714-614FamciclovirFamciclovirNorthStar RxLLCANDACurrent
16714-615FamciclovirFamciclovirNorthStar RxLLCANDACurrent
16714-615FamciclovirFamciclovirNorthStar RxLLCANDACurrent
16714-616FamciclovirFamciclovirNorthStar RxLLCANDACurrent
16714-616FamciclovirFamciclovirNorthStar RxLLCANDACurrent
50090-3066FamciclovirFamciclovirA-S Medication SolutionsANDACurrent
63187-919FAMCICLOVIRFamciclovirProficient Rx LPANDACurrent
63187-919FAMCICLOVIRFamciclovirProficient Rx LPANDACurrent
63187-920FAMCICLOVIRFamciclovirProficient Rx LPANDACurrent
63187-920FAMCICLOVIRFamciclovirProficient Rx LPANDACurrent
69097-269FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-269FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-269FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-271FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-271FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-271FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-272FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-272FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent
69097-272FAMCICLOVIRFamciclovirCipla USA Inc.ANDACurrent