Oseltamivir Phosphate

Basic Information

Product Name

FDA Product Code

50090-4613

Regulatory Information

NDC Product Code

50090-4613

Application Number

ANDA211125

Marketing Category

C73584

Effective Date

October 18, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspensionInitial U.S. Approval: 1999

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SORBITOL

Code: 506T60A25R

Class Code: IACT

MONOSODIUM CITRATE

Code: 68538UP9SE

Class Code: IACT

MALTODEXTRIN

Code: 7CVR7L4A2D

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

.ALPHA.-TOCOPHEROL, DL-

Code: 7QWA1RIO01

Class Code: IACT

OSELTAMIVIR PHOSPHATE

Quantity: 6 mg in 1 mL

Code: 4A3O49NGEZ

Class Code: ACTIM

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

OSELTAMIVIR ACID

Code: K6106LV5Q8

Basic Information

Regulatory Information

Company Information

Active Ingredients

SORBITOL

MONOSODIUM CITRATE

MALTODEXTRIN

BENZYL ALCOHOL

.ALPHA.-TOCOPHEROL, DL-

SACCHARIN SODIUM

SODIUM BENZOATE

TITANIUM DIOXIDE

XANTHAN GUM

PROPYLENE GLYCOL

Active Moieties

OSELTAMIVIR ACID