FDA.reportPublic FDA data

Application 065458

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALNoNo
002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALNoNo
003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-521piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-521piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-521piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-521piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-521piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-522piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-522piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-522piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-522piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-522piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-523piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-523piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-523piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-523piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
67457-523piperacillin and tazobactampiperacillin and tazobactamMylan Institutional LLCANDACurrent
72485-403Piperacillin and TazobactamPiperacillin and TazobactamArmas Pharmaceuticals Inc.ANDACurrent
72485-404Piperacillin and TazobactamPiperacillin and TazobactamArmas Pharmaceuticals Inc.ANDACurrent
82449-500piperacillin and tazobactampiperacillin and tazobactamSteriscience Specialties Private LimitedANDACurrent
82449-501piperacillin and tazobactampiperacillin and tazobactamSteriscience Specialties Private LimitedANDACurrent
82449-502piperacillin and tazobactampiperacillin and tazobactamSteriscience Specialties Private LimitedANDACurrent