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FDA Approval

Oseltamivir Phosphate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Strides Pharma Science Limited

DUNS: 650738743

Effective Date

December 8, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oseltamivir(45 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Oseltamivir Phosphate

Product Details

NDC Product Code

64380-798

Application Number

ANDA209421

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2022

Ingredients

OseltamivirActive

Code: 4A3O49NGEZClass: ACTIMQuantity: 45 mg in 1 1

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Oseltamivir Phosphate

Product Details

NDC Product Code

64380-797

Application Number

ANDA209421

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2022

Ingredients

OseltamivirActive

Code: 4A3O49NGEZClass: ACTIMQuantity: 30 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Oseltamivir Phosphate

Product Details

NDC Product Code

64380-799

Application Number

ANDA209421

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 8, 2022

Ingredients

OseltamivirActive

Code: 4A3O49NGEZClass: ACTIMQuantity: 75 mg in 1 1

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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