Application 209438

Type
ANDA
Sponsor
HETERO LABS LTD III

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
16714-817Oseltamivir PhosphateOseltamivir PhosphateNorthStar RxLLCANDACurrent
16714-818Oseltamivir PhosphateOseltamivir PhosphateNorthStar RxLLCANDACurrent
16714-819Oseltamivir PhosphateOseltamivir PhosphateNorthStar RxLLCANDACurrent
31722-630Oseltamivir PhosphateOseltamivir PhosphateCamber Pharmaceuticals, Inc.ANDACurrent
31722-631Oseltamivir PhosphateOseltamivir PhosphateCamber Pharmaceuticals, Inc.ANDACurrent
31722-632Oseltamivir PhosphateOseltamivir PhosphateCamber Pharmaceuticals, Inc.ANDACurrent
50090-4890Oseltamivir PhosphateOseltamivir PhosphateA-S Medication SolutionsANDACurrent
50090-6099Oseltamivir PhosphateOseltamivir PhosphateA-S Medication SolutionsANDACurrent
50090-6099Oseltamivir PhosphateOseltamivir PhosphateA-S Medication SolutionsANDACurrent
68071-2528Oseltamivir PhosphateOseltamivir PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2528Oseltamivir PhosphateOseltamivir PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2754Oseltamivir PhosphateOseltamivir PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3247Oseltamivir PhosphateOseltamivir PhosphateREMEDYREPACK INC.ANDACurrent
71205-617Oseltamivir PhosphateOseltamivir PhosphateProficient Rx LPANDACurrent
71205-617Oseltamivir PhosphateOseltamivir PhosphateProficient Rx LPANDACurrent
71205-680Oseltamivir PhosphateOseltamivir PhosphateProficient Rx LPANDACurrent
76420-289Oseltamivir PhosphateOseltamivir PhosphateAsclemed USA, Inc.ANDACurrent
76420-290Oseltamivir PhosphateOseltamivir PhosphateAsclemed USA, Inc.ANDACurrent
76420-291Oseltamivir PhosphateOseltamivir PhosphateAsclemed USA, Inc.ANDACurrent