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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211109

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XERAVA (ERAVACYCLINE DIHYDROCHLORIDE)
EQ 50MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: ERAVACYCLINE DIHYDROCHLORIDE
Proprietary Name: XERAVA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211109
Product Number: 001
Approval Date: Aug 27, 2018
Applicant Holder Full Name: TETRAPHASE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
XERAVA (ERAVACYCLINE DIHYDROCHLORIDE)
EQ 100MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: ERAVACYCLINE DIHYDROCHLORIDE
Proprietary Name: XERAVA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211109
Product Number: 002
Approval Date: Jun 3, 2020
Applicant Holder Full Name: TETRAPHASE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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