Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021131

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ZYVOX (LINEZOLID)
200MG/100ML (2MG/ML) Marketing Status: Prescription

Active Ingredient: LINEZOLID
Proprietary Name: ZYVOX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MG/100ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N021131
Product Number: 001
Approval Date: Apr 18, 2000
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYVOX (LINEZOLID)
600MG/300ML (2MG/ML) Marketing Status: Prescription

Active Ingredient: LINEZOLID
Proprietary Name: ZYVOX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 600MG/300ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021131
Product Number: 003
Approval Date: Apr 18, 2000
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYVOX (LINEZOLID)
400MG/200ML (2MG/ML) Marketing Status: Discontinued

Active Ingredient: LINEZOLID
Proprietary Name: ZYVOX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 400MG/200ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021131
Product Number: 002
Approval Date: Apr 18, 2000
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

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