Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021087

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TAMIFLU (OSELTAMIVIR PHOSPHATE)
EQ 30MG BASE
Marketing Status: Prescription
Active Ingredient: OSELTAMIVIR PHOSPHATE
Proprietary Name: TAMIFLU
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021087
Product Number: 003
Approval Date: Jul 2, 2007
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TAMIFLU (OSELTAMIVIR PHOSPHATE)
EQ 45MG BASE
Marketing Status: Prescription
Active Ingredient: OSELTAMIVIR PHOSPHATE
Proprietary Name: TAMIFLU
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021087
Product Number: 002
Approval Date: Jul 2, 2007
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TAMIFLU (OSELTAMIVIR PHOSPHATE)
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: OSELTAMIVIR PHOSPHATE
Proprietary Name: TAMIFLU
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021087
Product Number: 001
Approval Date: Oct 27, 1999
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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