Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200327

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TEFLARO (CEFTAROLINE FOSAMIL)
400MG/VIAL
Marketing Status: Prescription
Active Ingredient: CEFTAROLINE FOSAMIL
Proprietary Name: TEFLARO
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 400MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200327
Product Number: 001
Approval Date: Oct 29, 2010
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
TEFLARO (CEFTAROLINE FOSAMIL)
600MG/VIAL
Marketing Status: Prescription
Active Ingredient: CEFTAROLINE FOSAMIL
Proprietary Name: TEFLARO
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 600MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N200327
Product Number: 002
Approval Date: Oct 29, 2010
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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