FDA.reportPublic FDA data

Application 203807

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOZAPINECLOZAPINETABLET;ORAL25MGNoNo
002CLOZAPINECLOZAPINETABLET;ORAL100MGNoNo
003CLOZAPINECLOZAPINETABLET;ORAL50MGNoNo
004CLOZAPINECLOZAPINETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-085ClozapineClozapineGolden State Medical Supply, Inc.ANDACurrent
51407-085ClozapineClozapineGolden State Medical Supply, Inc.ANDACurrent
51407-086ClozapineClozapineGolden State Medical Supply, Inc.ANDACurrent
51407-086ClozapineClozapineGolden State Medical Supply, Inc.ANDACurrent
51862-271ClozapineClozapineMayne PharmaANDACurrent
51862-271ClozapineClozapineMayne PharmaANDACurrent
51862-272ClozapineClozapineMayne PharmaANDACurrent
51862-272ClozapineClozapineMayne PharmaANDACurrent
51862-272ClozapineClozapineMayne PharmaANDACurrent
51862-273ClozapineClozapineMayne PharmaANDACurrent
51862-273ClozapineClozapineMayne PharmaANDACurrent
51862-273ClozapineClozapineMayne PharmaANDACurrent
51862-273ClozapineClozapineMayne PharmaANDACurrent
51862-273ClozapineClozapineMayne PharmaANDACurrent
51862-274ClozapineClozapineMayne PharmaANDACurrent
51862-274ClozapineClozapineMayne PharmaANDACurrent
51862-274ClozapineClozapineMayne PharmaANDACurrent
51862-274ClozapineClozapineMayne PharmaANDACurrent
51862-274ClozapineClozapineMayne PharmaANDACurrent
51862-900ClozapineClozapineMayne PharmaANDACurrent
51862-900ClozapineClozapineMayne PharmaANDACurrent
51862-900ClozapineClozapineMayne PharmaANDACurrent
51862-901ClozapineClozapineMayne PharmaANDACurrent
51862-901ClozapineClozapineMayne PharmaANDACurrent
51862-901ClozapineClozapineMayne PharmaANDACurrent
51862-902ClozapineClozapineMayne PharmaANDACurrent
51862-902ClozapineClozapineMayne PharmaANDACurrent
51862-902ClozapineClozapineMayne PharmaANDACurrent
51862-903ClozapineClozapineMayne PharmaANDACurrent
51862-903ClozapineClozapineMayne PharmaANDACurrent
51862-903ClozapineClozapineMayne PharmaANDACurrent
60429-989ClozapineClozapineGSMS, IncorporatedANDACurrent
60429-989ClozapineClozapineGolden State Medical SupplyANDACurrent
60429-989ClozapineClozapineGolden State Medical Supply, Inc.ANDACurrent
60429-990ClozapineClozapineGSMS, IncorporatedANDACurrent
60429-990ClozapineClozapineGolden State Medical SupplyANDACurrent
60429-990ClozapineClozapineGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24117ORIG2015-10-09