Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091554

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: A091554
Product Number: 001
Approval Date: Sep 19, 2011
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information