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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208910

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FIRVANQ KIT (VANCOMYCIN HYDROCHLORIDE)
EQ 25MG BASE/ML
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: FIRVANQ KIT
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 25MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N208910
Product Number: 001
Approval Date: Jan 26, 2018
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FIRVANQ KIT (VANCOMYCIN HYDROCHLORIDE)
EQ 50MG BASE/ML
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: FIRVANQ KIT
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 50MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N208910
Product Number: 002
Approval Date: Jan 26, 2018
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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