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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214913

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VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 25MG BASE/ML
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 25MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214913
Product Number: 001
Approval Date: Nov 14, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
EQ 50MG BASE/ML
Marketing Status: Prescription
Active Ingredient: VANCOMYCIN HYDROCHLORIDE
Proprietary Name: VANCOMYCIN HYDROCHLORIDE
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 50MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214913
Product Number: 002
Approval Date: Nov 14, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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