FDA.reportPublic FDA data

Application 201025

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/VIALNoNo
002AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
003AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
004AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9817AMPICILLINAMPICILLINHenry Schein, Inc.ANDACurrent
52584-350AMPICILLINAMPICILLINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-350AMPICILLINAMPICILLINGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-350AMPICILLINAMPICILLINGeneral Injectables and Vaccines, Inc.ANDACurrent
67457-350AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-350AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-351AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-351AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-351AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-352AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-352AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-352AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-353AmpicillinAmpicillinMylan Institutional LLCANDACurrent
67457-353AmpicillinAmpicillinMylan Institutional LLCANDACurrent