Application 206074

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 4MG BASE/4ML (EQ 1MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-662TOPOTECANTOPOTECANMylan Institutional LLCANDACurrent
67457-662TOPOTECANTOPOTECANMylan Institutional LLCANDACurrent
67457-662TOPOTECANTOPOTECANMylan Institutional LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50989ORIG2018-01-08