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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211962

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VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 500MG BASE/100ML (EQ 5MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 500MG BASE/100ML (EQ 5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211962
Product Number: 001
Approval Date: Feb 15, 2019
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 750MG BASE/150ML (EQ 5MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 750MG BASE/150ML (EQ 5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211962
Product Number: 005
Approval Date: May 13, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 1GM BASE/200ML (EQ 5MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1GM BASE/200ML (EQ 5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211962
Product Number: 002
Approval Date: Feb 15, 2019
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211962
Product Number: 006
Approval Date: May 13, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211962
Product Number: 003
Approval Date: Feb 15, 2019
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211962
Product Number: 007
Approval Date: May 13, 2020
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 2GM BASE/400ML (EQ 5MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 2GM BASE/400ML (EQ 5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211962
Product Number: 004
Approval Date: Feb 15, 2019
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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