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Application 204040

Type
ANDA
Sponsor
EMCURE PHARMS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-290Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc.ANDACurrent
23155-290Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc.ANDACurrent
23155-290Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-290Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-290Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-290Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-785Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-785Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-786Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-786Amikacin SulfateAmikacin SulfateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent