Product Details for ANDA 205694
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 500MG BASE/VIAL
Marketing Status: Prescription
EQ 1GM BASE/VIAL
Marketing Status: Prescription
EQ 5GM BASE/VIAL
Marketing Status: Prescription
EQ 10GM BASE/VIAL
Marketing Status: Prescription
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: No
TE Code: AP
Application Number: A205694
Product Number: 001
Approval Date: Jan 21, 2016
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205694
Product Number: 001
Approval Date: Jan 21, 2016
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: No
TE Code: AP
Application Number: A205694
Product Number: 002
Approval Date: Jan 21, 2016
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205694
Product Number: 002
Approval Date: Jan 21, 2016
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: No
TE Code: AP
Application Number: A205694
Product Number: 003
Approval Date: Jun 6, 2023
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205694
Product Number: 003
Approval Date: Jun 6, 2023
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: No
TE Code: AP
Application Number: A205694
Product Number: 004
Approval Date: Jun 6, 2023
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205694
Product Number: 004
Approval Date: Jun 6, 2023
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information