FDA.reportPublic FDA data

Application 202197

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-649ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
67457-649ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent
67457-649ampicillin sodium and sulbactam sodiumampicillin sodium and sulbactam sodiumMylan Institutional LLCANDACurrent