Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-LaRoche Inc., LabelingRevision | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-LaRoche Inc., LabelingRevision | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision and Efficacy Supplement | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision and Efficacy Supplement | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche Inc., Labeling Revision | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche Inc., Labeling Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision | Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision | Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision | Tamiflu (oseltamivir phosphate) Oral Suspension, 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com