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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062663

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VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 500MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A062663
Product Number: 001
Approval Date: Mar 17, 1987
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 750MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 750MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A062663
Product Number: 005
Approval Date: Aug 17, 2016
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 1GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A062663
Product Number: 002
Approval Date: Jul 31, 1987
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 5GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A062663
Product Number: 003
Approval Date: Jun 3, 1988
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 10GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A062663
Product Number: 004
Approval Date: Nov 28, 1997
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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