FDA.reportPublic FDA data

Application 201741

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINEINJECTABLE;INTRAMUSCULAR10MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0955OlanzapineOlanzapineAmerican Regent, Inc.ANDACurrent
0517-0955OlanzapineOlanzapineAmerican Regent, Inc.ANDACurrent
0517-0955OlanzapineOlanzapineAmerican Regent, Inc.ANDACurrent
0517-0955OlanzapineOlanzapineAmerican Regent, Inc.ANDACurrent
64725-0955OlanzapineOlanzapineTYA PharmaceuticalsANDACurrent