FDA.reportPublic FDA data

Application 209113

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEFOR SUSPENSION;ORALEQ 6MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3710Oseltamivir PhosphateOseltamivir PhosphateA-S Medication SolutionsANDACurrent
50090-3710Oseltamivir PhosphateOseltamivir PhosphateA-S Medication SolutionsANDACurrent
68071-4743Oseltamivir PhosphateOseltamivir PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4743Oseltamivir PhosphateOseltamivir PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4743Oseltamivir PhosphateOseltamivir PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7600Oseltamivir PhosphateOseltamivir PhosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7600Oseltamivir PhosphateOseltamivir PhosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7600Oseltamivir PhosphateOseltamivir PhosphatePreferred Pharmaceuticals Inc.ANDACurrent
70710-1165Oseltamivir PhosphateOseltamivir PhosphateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1165OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1165Oseltamivir PhosphateOseltamivir PhosphateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1165Oseltamivir PhosphateOseltamivir PhosphateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1598Oseltamivir PhosphateOSELTAMIVIR ACIDCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49824ORIG2017-09-21
49796ORIG2017-09-19