FDA.reportPublic FDA data

Application 202595

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 30MG BASENoNo
002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 45MG BASENoNo
003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 75MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-468Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-468Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-468Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-468Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-468Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-469Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-469Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-469Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-469Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-469Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-470Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-470Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-470Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-470Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
47781-470Oseltamivir PhosphateOseltamivir phosphateAlvogen Inc.ANDACurrent
50090-2726Oseltamivir PhosphateOseltamivir phosphateA-S Medication SolutionsANDACurrent
53217-280Oseltamivir PhosphateOseltamivir phosphateAidarex Pharmaceuticals LLCANDACurrent
63739-038Oseltamivir PhosphateOseltamivir phosphateMcKesson Packaging ServicesANDACurrent
63739-038Oseltamivir PhosphateOseltamivir phosphateMcKesson Corporation dba SKY PackagingANDACurrent
63739-044Oseltamivir PhosphateOseltamivir phosphateMcKesson Packaging ServicesANDACurrent
63739-044Oseltamivir PhosphateOseltamivir phosphateMcKesson Corporation dba SKY PackagingANDACurrent
63739-050Oseltamivir PhosphateOseltamivir phosphateMcKesson Packaging ServicesANDACurrent
63739-050Oseltamivir PhosphateOseltamivir phosphateMcKesson Corporation dba SKY PackagingANDACurrent
68071-3105Oseltamivir PhosphateOseltamivir phosphateNuCare Pharmaceuticals, Inc.ANDACurrent
70518-0945Oseltamivir PhosphateOseltamivir phosphateREMEDYREPACK INC.ANDACurrent
70518-0945Oseltamivir PhosphateOseltamivir phosphateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45088ORIG2016-08-22