MedPath
FDA Product

oseltamivir phosphate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

oseltamivir phosphate

14335-380

Regulatory Information

14335-380

ANDA218009

C73584

November 29, 2023

USA

These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

654561638

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

OSELTAMIVIR PHOSPHATE

Quantity: 75 mg in 1 1

Code: 4A3O49NGEZ

Class Code: ACTIM

Active Moieties

OSELTAMIVIR ACID

Code: K6106LV5Q8

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