FDA.reportPublic FDA data

Application 202862

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

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
0615-8243OlanzapineOlanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8244OlanzapineOlanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8245OlanzapineOlanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8246OlanzapineOlanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
33342-067OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-067OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-067OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-067OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-067OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-068OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-068OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-068OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-068OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-068OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-069OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-069OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-069OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-069OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-069OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-070OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-070OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-070OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-070OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-070OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-071OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-071OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-071OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-071OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-071OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-072OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-072OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-072OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-072OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
33342-072OlanzapineOlanzapineMacleods Pharmaceuticals LimitedANDACurrent
55700-809OlanzapineOlanzapineQuality Care Products, LLCANDACurrent
55700-862OlanzapineOlanzapineQuality Care Products, LLCANDACurrent
63187-340OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-340OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-364OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-364OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-364OlanzapineOlanzapineProficient Rx LPANDACurrent
63629-8274OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
63629-8274OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
67046-525OlanzapineOlanzapineContract Pharmacy Services-PAANDACurrent
68071-2720OlanzapineOlanzapineNuCare Pharmceuticals,Inc.ANDACurrent
68788-7161OlanzapineOlanzapinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7161OlanzapineOlanzapinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7161OlanzapineOlanzapinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7161OlanzapineOlanzapinePreferred Pharmaceuticals Inc.ANDACurrent
70518-0921OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0921OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0921OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0935OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0935OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2337OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2337OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2337OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2375OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2375OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2375OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2698OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2698OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2698OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-2698OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
71205-487OlanzapineOlanzapineProficient Rx LPANDACurrent
71335-0534OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-0534OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-0534OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-0534OlanzapineOlanzapineBryant Ranch PrepackANDACurrent
71335-1760OlanzapineOlanzapineBryant Ranch PrepackANDACurrent