Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022110

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VIBATIV (TELAVANCIN HYDROCHLORIDE)
EQ 750MG BASE/VIAL Marketing Status: Prescription

Active Ingredient: TELAVANCIN HYDROCHLORIDE
Proprietary Name: VIBATIV
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 750MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022110
Product Number: 002
Approval Date: Sep 11, 2009
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIBATIV (TELAVANCIN HYDROCHLORIDE)
EQ 250MG BASE/VIAL Marketing Status: Discontinued

Active Ingredient: TELAVANCIN HYDROCHLORIDE
Proprietary Name: VIBATIV
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 250MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022110
Product Number: 001
Approval Date: Sep 11, 2009
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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