FDA.reportPublic FDA data

Application 090798

Type
ANDA
Sponsor
APOTEX INC

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
43353-954OlanzapineOlanzapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3081OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
50090-3100OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
50268-609OlanzapineOlanzapineAvPAKANDACurrent
50268-609OlanzapineOlanzapineAvPAKANDACurrent
50268-610OlanzapineOlanzapineAvPAKANDACurrent
50268-610OlanzapineOlanzapineAvPAKANDACurrent
50268-611OlanzapineOlanzapineAvPAKANDACurrent
50268-611OlanzapineOlanzapineAvPAKANDACurrent
50268-612OlanzapineOlanzapineAvPAKANDACurrent
50268-612OlanzapineOlanzapineAvPAKANDACurrent
50268-613OlanzapineOlanzapineAvPAKANDACurrent
50268-613OlanzapineOlanzapineAvPAKANDACurrent
50268-614OlanzapineOlanzapineAvPAKANDACurrent
50268-614OlanzapineOlanzapineAvPAKANDACurrent
53002-1505OlanzapineOlanzapineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1505OlanzapineOlanzapineRPK Pharmaceuticals, Inc.ANDACurrent
55700-571OlanzapineOlanzapineLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-3111OlanzapineOlanzapineClinical Solutions Wholesale, LLCANDACurrent
58118-3111OlanzapineOlanzapineClinical Solutions Wholesale, LLCANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-620OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-621OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-622OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-623OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-624OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical Supply, Inc.ANDACurrent
60429-625OlanzapineOlanzapineGolden State Medical SupplyANDACurrent
60505-3110OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3110OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3110OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3111OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3111OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3111OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3112OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3112OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3112OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3113OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3113OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3113OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3114OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3114OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3114OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3140OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3140OlanzapineOlanzapineApotex Corp.ANDACurrent
60505-3140OlanzapineOlanzapineApotex Corp.ANDACurrent
63187-429OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-429OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-453OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-453OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-844OlanzapineOlanzapineProficient Rx LPANDACurrent
63187-844OlanzapineOlanzapineProficient Rx LPANDACurrent
67046-522OlanzapineOlanzapineContract Pharmacy Services-PAANDACurrent
67046-523OlanzapineOlanzapineContract Pharmacy Services-PAANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0314OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31496ORIG2012-04-25