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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 021087


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NDA 021087 describes TAMIFLU, which is a drug marketed by Roche and is included in two NDAs. It is available from two suppliers. Additional details are available on the TAMIFLU profile page.

The generic ingredient in TAMIFLU is oseltamivir phosphate. There are eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 021087
Tradename:TAMIFLU
Applicant:Roche
Ingredient:oseltamivir phosphate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021087
Suppliers and Packaging for NDA: 021087
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087 NDA Genentech, Inc. 0004-0800 0004-0800-07 1 BOTTLE, PLASTIC in 1 CARTON (0004-0800-07) > 10 CAPSULE in 1 BOTTLE, PLASTIC
TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087 NDA Genentech, Inc. 0004-0800 0004-0800-08 1 BOTTLE, PLASTIC in 1 CARTON (0004-0800-08) > 10 CAPSULE in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 021087
Tradename Dosage Ingredient NDA Submissiondate
TAMIFLU CAPSULE;ORAL oseltamivir phosphate 021087 2011-08-02
TAMIFLU CAPSULE;ORAL oseltamivir phosphate 021087 2010-11-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Oct 27, 1999TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 2, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING INFLUENZA VIRUS RESISTANCE TO OSELTAMIVIR IN IMMUNOCOMPROMISED PATIENTS

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 45MG BASE
Approval Date:Jul 2, 2007TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 2, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING INFLUENZA VIRUS RESISTANCE TO OSELTAMIVIR IN IMMUNOCOMPROMISED PATIENTS

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 30MG BASE
Approval Date:Jul 2, 2007TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 2, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING INFLUENZA VIRUS RESISTANCE TO OSELTAMIVIR IN IMMUNOCOMPROMISED PATIENTS

Expired US Patents for NDA 021087

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-001 Oct 27, 1999   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-002 Jul 2, 2007   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate CAPSULE;ORAL 021087-003 Jul 2, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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