Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207001

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

Active Ingredient: LINEZOLID
Proprietary Name: LINEZOLID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MG/100ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207001
Product Number: 001
Approval Date: Jul 7, 2017
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: LINEZOLID
Proprietary Name: LINEZOLID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 600MG/300ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207001
Product Number: 002
Approval Date: Jul 7, 2017
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information