FDA.reportPublic FDA data

Application 203708

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
65862-656OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-656OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-656OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-656OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-657OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-657OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-657OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-657OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-658OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-658OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-658OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-658OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-659OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-659OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-659OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
65862-659OlanzapineOlanzapineAurobindo Pharma LimitedANDACurrent
66993-686OlanzapineOlanzapinePrasco LaboratoriesANDACurrent
66993-687OlanzapineOlanzapinePrasco LaboratoriesANDACurrent
66993-688OlanzapineOlanzapinePrasco LaboratoriesANDACurrent
66993-689OlanzapineOlanzapinePrasco LaboratoriesANDACurrent