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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

Zydus Lifesciences Limited

DUNS: 918596198

Effective Date

October 31, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oseltamivir(45 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Zydus Lifesciences Limited

Labeler

Zydus Lifesciences Limited

DUNS Number

918596198

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

70771-1711

Application Number

ANDA208578

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 31, 2022

Ingredients

OseltamivirActive

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

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

OSELTAMIVIR PHOSPHATE

Product Details

NDC Product Code

70771-1710

Application Number

ANDA208578

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 31, 2022

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

OseltamivirActive

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

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

OSELTAMIVIR PHOSPHATE

Product Details

NDC Product Code

70771-1712

Application Number

ANDA208578

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 31, 2022

Ingredients

OseltamivirActive

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

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

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