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FDA Approval Activities for this Drug… Tamiflu (oseltamivir phosphate) capsules and oral suspension, Hoffman-La Roche NDA 21-087/S-010 & 21-246/S-007 4/26/02 5/2/02 4/26/02 Tamiflu (oseltamivir phosphate) capsules and oral suspension, Hoffman-La Roche NDA 21-087/S-010 & 21-246/S-007 4/9/02 4/16/02 4/9/02 Tamiflu (oseltamivir phosphate) capsules and oral suspension, Hoffman-La Roche NDA 21-087/S-009 & 21-246/S-004 11/5/01 4/22/03 Tamiflu (oseltamivir phosphate) capsules and oral suspension, Hoffman-La Roche NDA 21-087/S-008 & 21-246/S-003 07/24/01 05/08/03 Tamiflu (oseltamivir phosphate) capsules and oral suspension, Hoffman-La Roche NDA 21-087/S5/S6 07/24/01 05/08/03 Tamiflu (oseltamivir phospate) Suspension,12mg/mL [Patient Labeling] Hoffman-La Roche NDA 21-246 12/14/00 12/15/00 12/14/00 Tamiflu indication: Tamiflu is now available for oral use for the treatment of uncomplicated acute illness due to influenza in patients older than one year of age who have been symptomatic for no longer than 2 days. Tamiflu treatment significantly reduced the total composite time to freedom from illness (resolution of fever, alleviation of coryza and cough, and parental opinion of return to normal health and activity) by 1.5 days compared to placebo. Tamiflu (oseltamivir phospate) Suspension,12mg/mL Hoffman-La Roche NDA 21-246/S1 7/24/01 5/1/03 Tamiflu (oseltamivir phospate) Suspension,12mg/mL Hoffman-La Roche NDA 21-246/S3 7/24/01 5/1/03 Tamiflu (oseltamivir phospate), 75 mg capsule [Patient Labeling] Hoffman-La Roche NDA 21-087/SE1-002 11/17/00 12/15/00 12/14/00 Tamiflu (oseltamivir phospate)75 mg capsule Hoffman-La Roche NDA 21-087 Tamiflu (oseltamivir phosphate) capsules, Hoffmann-La Roche Tamiflu (oseltamivir phosphate) dry powder for suspension, Hoffmann-La Roche | TAMIFLU (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Control Supplement | Tamiflu (oseltamivir phosphate) capsules, Hoffman-La Roche, Labeling Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Labeling Revision | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffman-La Roche, Patient Population Altered | Tamiflu (oseltamivir phosphate) Capsules, Hoffman-La Roche, Patient Population Altered | Tamiflu (oseltamivir phosphate) Oral Suspension and Capsules, Hoffman-La Roche, Labeling RevisionTamiflu (oseltamivir phosphate) Oral Suspension, Hoffman-La Roche, Formulation Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffman-La Roche, Formulation Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffman La Roche, Labeling Revision | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffman La Roche, Labeling Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffman-La Roche, Labeling Revision | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffman-La Roche, Labeling Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com