01 1ALP Pharm
02 1HEC Pharm
03 1Indoco Remedies Limited
04 1Maithri Drugs
05 1Micro Labs Limited
06 1Blank
01 4BESIFLOXACIN HYDROCHLORIDE
02 1BESIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE
03 1SS734
01 2China
02 3India
03 1Blank
01 4Active
02 2Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32611
Submission : 2018-03-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32160
Submission : 2017-11-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-06
Pay. Date : 2017-02-16
DMF Number : 29303
Submission : 2015-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35809
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-22
Pay. Date : 2017-12-02
DMF Number : 31989
Submission : 2017-11-30
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16249
Submission : 2002-11-20
Status : Inactive
Type : II
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