FDA.reportPublic FDA data

Application 091265

Type
ANDA
Sponsor
APOTEX INC

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
50090-3405OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-261OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-262OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-263OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
51407-264OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3275OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3276OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3277OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3278OlanzapineOlanzapineApotex Corp.ANDACurrent
63629-8714OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8714OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8714OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8717OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8717OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8717OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8718OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8718OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8718OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8719OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8719OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8719OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
70518-1154OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1154OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1206OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1206OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1207OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-1207OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
72789-265OlanzapineOlanzapinePD-Rx Pharmaceuticals, Inc.ANDACurrent