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FDA Approval

oseltamavir phosphate

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

FDA Approval Summary

Company

Macleods Pharmaceuticals Limited

DUNS: 862128535

Effective Date

September 5, 2022

Labeling Type

Human Prescription Drug Label

Active Ingredients

Oseltamivir(30 mg in 1 1)

Manufacturing Establishments1

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

Macleods Pharmaceuticals Limited

Labeler

Macleods Pharmaceuticals Limited

DUNS Number

676369519

Products3

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

oseltamavir phosphate

Product Details

NDC Product Code

33342-256

Application Number

ANDA207211

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 5, 2022

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

OseltamivirActive

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

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

oseltamavir phosphate

Product Details

NDC Product Code

33342-257

Application Number

ANDA207211

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 5, 2022

Ingredients

OseltamivirActive

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

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

oseltamavir phosphate

Product Details

NDC Product Code

33342-258

Application Number

ANDA207211

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 5, 2022

Ingredients

OseltamivirActive

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

POVIDONEInactive

Code: FZ989GH94EClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

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