FDA.reportPublic FDA data

Application 203385

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DACTINOMYCINDACTINOMYCININJECTABLE;INJECTION0.5MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-431DACTINOMYCINDACTINOMYCINAuroMedics Pharma LLCANDACurrent
55150-928DACTINOMYCINDACTINOMYCINAuroMedics Pharma LLCANDACurrent
67457-513DactinomycinDactinomycinMylan Institutional LLCANDACurrent
67457-513DactinomycinDactinomycinMylan Institutional LLCANDACurrent
67457-928DactinomycinDactinomycinMylan Institutional LLCANDACurrent
67457-928DactinomycinDactinomycinMylan Institutional LLCANDACurrent