FDA.reportPublic FDA data

Application 065506

Type
ANDA
Sponsor
MYLAN ASI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCININJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-112AzithromycinazithromycinSagent PharmaceuticalsANDACurrent
67457-860AzithromycinazithromycinMylan Institutional LLCANDACurrent
67457-860AzithromycinazithromycinMylan Institutional LLCANDACurrent
67457-860AzithromycinazithromycinMylan Institutional LLCANDACurrent