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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215821

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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: No
TE Code: AP
Application Number: A215821
Product Number: 001
Approval Date: Nov 18, 2021
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS 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: No
TE Code: AP
Application Number: A215821
Product Number: 002
Approval Date: Nov 18, 2021
Applicant Holder Full Name: SLATE RUN PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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