FDA.reportPublic FDA data

Application 204319

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET;ORAL2.5MGNoNo
002OLANZAPINEOLANZAPINETABLET;ORAL5MGNoNo
003OLANZAPINEOLANZAPINETABLET;ORAL7.5MGNoNo
004OLANZAPINEOLANZAPINETABLET;ORAL10MGNoNo
005OLANZAPINEOLANZAPINETABLET;ORAL15MGNoNo
006OLANZAPINEOLANZAPINETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3933OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
50090-3934OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
50090-4040OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
53002-2505OlanzapineOlanzapineRPK Pharmaceuticals, Inc.ANDACurrent
55700-665OlanzapineOlanzapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-743OlanzapineOlanzapineQuality Care Products, LLCANDACurrent
55700-743OlanzapineOlanzapineQuality Care Products, LLCANDACurrent
58118-0381OlanzapineOlanzapineClinical Solutions Wholesale, LLCANDACurrent
58118-0381OlanzapineOlanzapineClinical Solutions Wholesale, LLCANDACurrent
58118-0381OlanzapineOlanzapineClinical Solutions Wholesale, LLCANDACurrent
63629-7902OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-7902OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-7902OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
67184-0561OlanzapineOlanzapineQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0562OlanzapineOlanzapineQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0563OlanzapineOlanzapineQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0564OlanzapineOlanzapineQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0565OlanzapineOlanzapineQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0566OlanzapineOlanzapineQilu Pharmaceutical Co., Ltd.ANDACurrent
69543-380OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-380OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-380OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-380OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-381OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-381OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-381OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-381OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-382OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-382OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-382OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-382OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-383OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-383OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-383OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-383OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-384OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-384OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-384OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-384OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-385OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-385OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-385OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
69543-385OlanzapineOlanzapineVirtus Pharmaceuticals, LLCANDACurrent
70518-2299OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2299OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2299OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2623OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2623OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2623OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-3189OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-3447OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
71335-1168OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-1168OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-1168OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-1168OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-1363OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-1363OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-1363OlanzapineOlanzapineBryant Ranch PrepackANDACurrent