FDA.reportPublic FDA data

Application 213510

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/2ML (10MG/ML)NoNo
002DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/8ML (10MG/ML)NoNo
003DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/16ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-399DocetaxelDocetaxelGland Pharma LimitedANDACurrent
68083-400DocetaxelDocetaxelGland Pharma LimitedANDACurrent
68083-401DocetaxelDocetaxelGland Pharma LimitedANDACurrent
70700-174DocetaxelDocetaxelXiromed LLCANDACurrent
70700-174DocetaxelDocetaxelXiromed LLCANDACurrent
70700-174DocetaxelDocetaxelXiromed LLCANDACurrent
70700-175DocetaxelDocetaxelXiromed LLCANDACurrent
70700-175DocetaxelDocetaxelXiromed LLCANDACurrent
70700-175DocetaxelDocetaxelXiromed LLCANDACurrent
70700-176DocetaxelDocetaxelXiromed LLCANDACurrent
70700-176DocetaxelDocetaxelXiromed LLCANDACurrent
70700-176DocetaxelDocetaxelXiromed LLCANDACurrent