FDA.reportPublic FDA data

Application 091606

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMIVUDINELAMIVUDINETABLET;ORAL150MGNoNo
002LAMIVUDINELAMIVUDINETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6583LAMIVUDINElamivudineMajor PharmaceuticalsANDACurrent
0904-6583LAMIVUDINElamivudineMajor PharmaceuticalsANDACurrent
53808-0843LAMIVUDINElamivudineState of Florida DOH Central PharmacyANDACurrent
53808-0844LAMIVUDINElamivudineState of Florida DOH Central PharmacyANDACurrent
60429-353LAMIVUDINElamivudineGolden State Medical Supply, Inc.ANDACurrent
60429-353LAMIVUDINElamivudineGolden State Medical Supply, Inc.ANDACurrent
60429-353LAMIVUDINElamivudineGolden State Medical Supply, Inc.ANDACurrent
60429-354LAMIVUDINElamivudineGolden State Medical Supply, Inc.ANDACurrent
60429-354LAMIVUDINElamivudineGolden State Medical Supply, Inc.ANDACurrent
60429-354LAMIVUDINElamivudineGolden State Medical Supply, Inc.ANDACurrent
60505-3251LAMIVUDINElamivudineApotex Corp.ANDACurrent
60505-3251LAMIVUDINElamivudineApotex Corp.ANDACurrent
60505-3251LAMIVUDINElamivudineApotex Corp.ANDACurrent
60505-3252LAMIVUDINElamivudineApotex Corp.ANDACurrent
60505-3252LAMIVUDINElamivudineApotex Corp.ANDACurrent
60505-3252LAMIVUDINElamivudineApotex Corp.ANDACurrent
60687-720LamivudineLamivudineAmerican Health PackagingANDACurrent