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FDA Drug information

OSELTAMIVIR PHOSPHATE

Read time: 1 mins
Marketing start date: 23 Nov 2024

Summary of product characteristics


Effective Time

20221031

Version

2

Spl Product Data Elements

OSELTAMIVIR PHOSPHATE oseltamivir phosphate OSELTAMIVIR PHOSPHATE OSELTAMIVIR ACID CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE GELATIN POVIDONE K30 SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE STARCH, CORN TALC TITANIUM DIOXIDE WATER WHITE N;1008 OSELTAMIVIR PHOSPHATE oseltamivir phosphate OSELTAMIVIR PHOSPHATE OSELTAMIVIR ACID CROSCARMELLOSE SODIUM D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN POVIDONE K30 SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE STARCH, CORN TALC TITANIUM DIOXIDE WATER Light Blue Gray Light Blue Gray N;1009 OSELTAMIVIR PHOSPHATE oseltamivir phosphate OSELTAMIVIR PHOSPHATE OSELTAMIVIR ACID CROSCARMELLOSE SODIUM D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN POVIDONE K30 SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE STARCH, CORN TALC TITANIUM DIOXIDE WATER Light Blue Gray N;1010

Application Number

ANDA208578

Brand Name

OSELTAMIVIR PHOSPHATE

Generic Name

oseltamivir phosphate

Product Ndc

70771-1712

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1710-2 OSELTAMIVIR PHOSPHATE Capsules, USP 30* mg *Each capsule contains oseltamivir phosphate equivalent to 30 mg oseltamivir (free base). 10 Capsules (1 x 10 Unit-Dose) Rx only NDC 70771-1711-2 OSELTAMIVIR PHOSPHATE Capsules, USP 45* mg *Each capsule contains oseltamivir phosphate equivalent to 45 mg oseltamivir (free base). 10 Capsules (1 x 10 Unit-Dose) Rx only NDC 70771-1712-2 OSELTAMIVIR PHOSPHATE Capsules, USP 75* mg *Each capsule contains oseltamivir phosphate equivalent to 75 mg oseltamivir (free base). 10 Capsules (1 x 10 Unit-Dose) Rx only 30 mg label 45 mg label 75 mg label

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