Product Details for ANDA 062682
VANCOLED (VANCOMYCIN HYDROCHLORIDE)
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 001
Approval Date: Jul 22, 1986
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
VANCOLED (VANCOMYCIN HYDROCHLORIDE)
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 001
Approval Date: Jul 22, 1986
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 002
Approval Date: Mar 30, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
VANCOLED (VANCOMYCIN HYDROCHLORIDE)
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 002
Approval Date: Mar 30, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 003
Approval Date: May 11, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
VANCOLED (VANCOMYCIN HYDROCHLORIDE)
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 003
Approval Date: May 11, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 004
Approval Date: May 11, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
VANCOLED (VANCOMYCIN HYDROCHLORIDE)
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 004
Approval Date: May 11, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 005
Approval Date: May 11, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: VANCOLED
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A062682
Product Number: 005
Approval Date: May 11, 1988
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information