Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 050671

Expand all

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (VANCOMYCIN HYDROCHLORIDE)
EQ 500MG BASE/100ML (EQ 5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
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: N050671
Product Number: 001
Approval Date: Apr 29, 1993
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (VANCOMYCIN HYDROCHLORIDE)
EQ 750MG BASE/150ML (EQ 5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
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: N050671
Product Number: 002
Approval Date: Dec 20, 2010
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (VANCOMYCIN HYDROCHLORIDE)
EQ 1GM BASE/200ML (EQ 5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
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: N050671
Product Number: 003
Approval Date: Mar 1, 1999
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (VANCOMYCIN HYDROCHLORIDE)
EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
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: N050671
Product Number: 004
Approval Date: Jan 25, 2024
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (VANCOMYCIN HYDROCHLORIDE)
EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
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: N050671
Product Number: 005
Approval Date: Jan 25, 2024
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information