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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

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Effective Date

August 25, 2023

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.

Amneal Pharmaceuticals Private Limited

Labeler

Amneal Pharmaceuticals NY LLC

DUNS Number

650762060

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

60219-1264

Application Number

ANDA209093

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 26, 2022

Ingredients

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

OseltamivirActive

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

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

Oseltamivir Phosphate

Product Details

NDC Product Code

60219-1266

Application Number

ANDA209093

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 26, 2022

Ingredients

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

OseltamivirActive

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

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

Oseltamivir Phosphate

Product Details

NDC Product Code

60219-1265

Application Number

ANDA209093

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 26, 2022

Ingredients

OseltamivirActive

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

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

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