FDA.reportPublic FDA data

Application 064045

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIKACIN SULFATEAMIKACIN SULFATEINJECTABLE;INJECTIONEQ 50MG BASE/MLNoNo
002AMIKACIN SULFATEAMIKACIN SULFATEINJECTABLE;INJECTIONEQ 250MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-9032Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent
0703-9032Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent
0703-9032Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent
0703-9032Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent
0703-9040Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent
0703-9040Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent
0703-9040Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent
0703-9040Amikacin SulfateAmikacin SulfateTeva Parenteral Medicines, Inc.ANDACurrent