FDA.reportPublic FDA data

Application 209634

Type
ANDA
Sponsor
CIPLA

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
69097-369Docetaxel AnhydrousDocetaxel AnhydrousCipla USA Inc.ANDACurrent
69097-369Docetaxel AnhydrousDocetaxel AnhydrousCipla USA Inc.ANDACurrent
69097-371Docetaxel AnhydrousDocetaxel AnhydrousCipla USA Inc.ANDACurrent
69097-371Docetaxel AnhydrousDocetaxel AnhydrousCipla USA Inc.ANDACurrent
69097-372Docetaxel AnhydrousDocetaxel AnhydrousCipla USA Inc.ANDACurrent
69097-372Docetaxel AnhydrousDocetaxel AnhydrousCipla USA Inc.ANDACurrent
71288-143Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-143Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-144Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-144Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-144Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-150Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-150Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-151Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
71288-151Docetaxel anhydrousDocetaxel anhydrousMeitheal Pharmaceuticals IncANDACurrent
73358-210Docetaxel AnhydrousDocetaxel AnhydrousCurae Pharma360 Inc.ANDACurrent