FDA.reportPublic FDA data

Application 078109

Type
ANDA
Sponsor
PAR PHARM

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
49884-320OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-320OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-320OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-320OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-320OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-320OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-321OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-321OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-321OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-321OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-321OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-321OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-322OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-322OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-322OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-322OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-322OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-322OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-323OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-323OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-323OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-323OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-323OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
49884-323OlanzapineolanzapinePar Pharmaceutical, Inc.ANDACurrent
50090-3958OlanzapineolanzapineA-S Medication SolutionsANDACurrent
50090-3958OlanzapineolanzapineA-S Medication SolutionsANDACurrent
50090-3958OlanzapineolanzapineA-S Medication SolutionsANDACurrent
50090-3967OlanzapineolanzapineA-S Medication SolutionsANDACurrent
50090-3967OlanzapineolanzapineA-S Medication SolutionsANDACurrent
50090-3967OlanzapineolanzapineA-S Medication SolutionsANDACurrent
63629-2237OlanzapineolanzapineBryant Ranch PrepackANDACurrent
63629-2237OlanzapineolanzapineBryant Ranch PrepackANDACurrent
63629-2237OlanzapineolanzapineBryant Ranch PrepackANDACurrent
64380-172OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent
64380-172OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent
64380-173OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent
64380-173OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent
64380-174OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent
64380-174OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent
64380-175OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent
64380-175OlanzapineolanzapineStrides Pharma Science LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31332ORIG2011-10-26