LILLY FDA Approval ANDA 062557

ANDA 062557

LILLY

FDA Drug Application

Application #062557

Application Sponsors

ANDA 062557LILLY

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0KEFZOLCEFAZOLIN SODIUM
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0KEFZOLCEFAZOLIN SODIUM

FDA Submissions

ORIG1AP1985-09-10
LABELING; LabelingSUPPL6AP1992-01-22
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1991-07-16
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1992-10-30
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2002-09-05
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-09-30

Submissions Property Types

ORIG1Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL13Null0
SUPPL14Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62557
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.