Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021130

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ZYVOX (LINEZOLID)
600MG
Marketing Status: Prescription

Active Ingredient: LINEZOLID
Proprietary Name: ZYVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021130
Product Number: 002
Approval Date: Apr 18, 2000
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYVOX (LINEZOLID)
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: LINEZOLID
Proprietary Name: ZYVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021130
Product Number: 001
Approval Date: Apr 18, 2000
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information