Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021246

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TAMIFLU (OSELTAMIVIR PHOSPHATE)
EQ 6MG BASE/ML
Marketing Status: Prescription

Active Ingredient: OSELTAMIVIR PHOSPHATE
Proprietary Name: TAMIFLU
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 6MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021246
Product Number: 002
Approval Date: Mar 21, 2011
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TAMIFLU (OSELTAMIVIR PHOSPHATE)
EQ 12MG BASE/ML
Marketing Status: Discontinued

Active Ingredient: OSELTAMIVIR PHOSPHATE
Proprietary Name: TAMIFLU
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 12MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021246
Product Number: 001
Approval Date: Dec 14, 2000
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information