FDA.reportPublic FDA data

Application 207326

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PACITAXELPACLITAXELINJECTABLE;INJECTION6MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-593PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-593PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-594PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-594PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-595PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-595PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-595PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-595PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
47781-595PaclitaxelpaclitaxelAlvogen Inc.ANDACurrent
51991-936PaclitaxelPaclitaxelBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-937PaclitaxelPaclitaxelBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-938PaclitaxelPaclitaxelBreckenridge Pharmaceutical, Inc.ANDACurrent
68083-178PACLITAXELpaclitaxelGland Pharma LimitedANDACurrent
68083-179PACLITAXELpaclitaxelGland Pharma LimitedANDACurrent
68083-180PACLITAXELpaclitaxelGland Pharma LimitedANDACurrent
70860-200PaclitaxelpaclitaxelAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-215PaclitaxelpaclitaxelAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-215PaclitaxelpaclitaxelAthenex Pharmaceutical Division, LLC.ANDACurrent