01 1LG Life Sciences
02 1Maithri Drugs
03 1Orchid Pharma
01 1GEMIFLOXACIN MESYLATE
02 1GEMIFLOXACIN MESYLATE (NON-STERILE BULK API)
03 1GEMIFLOXACIN MESYLATE USP
01 2India
02 1South Korea
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14524
Submission : 1999-11-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37897
Submission : 2023-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21238
Submission : 2008-01-31
Status : Active
Type : II
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