01 2Ercros
02 1F.I.S. Fabbrica Italiana Sintetici
03 1HONOUR LAB LTD
04 1Interquim Mexico
05 1Quimica Sintetica
01 1FOSFOMYCIN PHENYLAMMONIUM SALT
02 1FOSFOMYCIN TROMETAMOL
03 1FOSFOMYCIN TROMETAMOL (TROMETHAMINE) PH EUR/USP
04 3FOSFOMYCIN TROMETHAMINE
01 1India
02 1Italy
03 1Mexico
04 3Spain
01 6Active
01 3Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-20
Pay. Date : 2016-12-22
DMF Number : 31195
Submission : 2017-02-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11582
Submission : 1995-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10891
Submission : 1994-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40335
Submission : 2024-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-04
Pay. Date : 2017-09-27
DMF Number : 31656
Submission : 2017-04-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-05
Pay. Date : 2018-12-06
DMF Number : 33294
Submission : 2018-11-02
Status : Active
Type : II
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