FDA.reportPublic FDA data

Application 078503

Type
ANDA
Sponsor
OSMOTICA PHARM US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-633Oxybutynin ChlorideOxybutynin ChlorideAvKAREANDACurrent
42291-633Oxybutynin ChlorideOxybutynin ChlorideAvKARE, Inc.ANDACurrent
42291-634Oxybutynin ChlorideOxybutynin ChlorideAvKAREANDACurrent
42291-634Oxybutynin ChlorideOxybutynin ChlorideAvKARE, Inc.ANDACurrent
42291-635Oxybutynin ChlorideOxybutynin ChlorideAvKARE, Inc.ANDACurrent
42291-635Oxybutynin ChlorideOxybutynin ChlorideAvKAREANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-790Oxybutynin ChlorideOxybutynin ChloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-282Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-284Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-285Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-322Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-769Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
50090-4192Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4192Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50090-4192Oxybutynin ChlorideOxybutynin ChlorideA-S Medication SolutionsANDACurrent
50268-627Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-627Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-628Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-628Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-629Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
50268-629Oxybutynin ChlorideOxybutynin ChlorideAvPAKANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc..ANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-270Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc..ANDACurrent
62175-271Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc..ANDACurrent
62175-272Oxybutynin ChlorideOxybutynin ChlorideLannett Company, Inc.ANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-548Oxybutynin ChlorideOxybutynin ChlorideMcKesson CorporationANDACurrent
68071-2013Oxybutynin ChlorideOxybutynin ChlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-480Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
68084-610Oxybutynin ChlorideOxybutynin ChlorideAmerican Health PackagingANDACurrent
71335-0669Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent
71335-0669Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent
71335-0669Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22622ORIG2013-08-09