FDA.reportPublic FDA data

Application 200221

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL5MGNoNo
002OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo
003OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL15MGNoNo
004OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6111OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
59746-306OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
59746-306OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
59746-307OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
59746-307OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
59746-308OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
59746-308OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
59746-309OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
59746-309OlanzapineOlanzapineJubilant Cadista Pharmaceuticals IncANDACurrent
63629-7514OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-7514OlanzapineOlanzapineBryant Ranch PrepackANDACurrent