FDA.reportPublic FDA data

Application 201024

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALNoNo
002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-348ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
67457-348ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
67457-348ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
67457-349ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
67457-349ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
67457-349ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
82449-900ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumSteriscience Specialties Private LimitedANDACurrent
82449-901ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumSteriscience Specialties Private LimitedANDACurrent