approval package for - food and drug administration...lgc 5303 6515 lilly research laboratories...
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CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for:
APPLICATION NUMBER:
ANDA 61-667
Name: Vancomycin Hydrochloride for Oral Solution, USP
Sponsor: Lilly Research Laboratories, A Division of Eli Lilly and Company
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
ANDA 61-667
CONTENTS
Reviews / Information Included in this Review July 13, 1983 Approval Sign-Off X Tentative Approval Letter Labeling X Labeling Reviews Medical Reviews X Chemistry Reviews X Bioequivalence Reviews Statistical Reviews Microbiology Reviews Administrative & Correspondence Documents X
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
ANDA 61-667
July 13, 1983 APPROVAL SIGN-OFF
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