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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

Approval Package for - Food and Drug Administration...LGC 5303 6515 LILLY RESEARCH LABORATORIES DIVISION OF ELI LILLY AND COMPANY INDIANAPOLIS, 46206 TELEPHONE (317) 636-2211 August

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Page 1: Approval Package for - Food and Drug Administration...LGC 5303 6515 LILLY RESEARCH LABORATORIES DIVISION OF ELI LILLY AND COMPANY INDIANAPOLIS, 46206 TELEPHONE (317) 636-2211 August

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

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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

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CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

ANDA 61-667

July 13, 1983 APPROVAL SIGN-OFF

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(b) (4)

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