FDA.reportPublic FDA data

Application 091480

Type
ANDA
Sponsor
APOTEX

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
60429-359FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-359FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-359FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-360FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-360FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-360FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-361FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-361FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-361FAMCICLOVIRFAMCICLOVIRGolden State Medical Supply, Inc.ANDACurrent
60505-3245FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3245FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3245FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3246FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3246FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3246FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3247FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3247FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60505-3247FAMCICLOVIRFAMCICLOVIRApotex Corp.ANDACurrent
60687-103FAMCICLOVIRFAMCICLOVIRAmerican Health PackagingANDACurrent
60687-103FAMCICLOVIRFAMCICLOVIRAmerican Health PackagingANDACurrent