01 1Actylis
02 1Calyx Chemicals & Pharmaceuticals Limited
03 1F. Hoffmann-La Roche
04 1Laurus Labs
05 1Maithri Drugs
06 1Nantong Jinghua Pharmaceutical
07 1Solara Active Pharma Sciences
08 1Viatris
01 15-FLUOROCYTOSINE (FLUCYTOSINE) USP
02 2FLUCYTOSINE
03 1FLUCYTOSINE CAPSULES AND MATCHING PLACEBO
04 3FLUCYTOSINE USP
05 1FLUCYTOSINE, USP
01 1China
02 4India
03 1Switzerland
04 2U.S.A
01 6Active
02 2Inactive
01 5Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15476
Submission : 2001-06-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23503
Submission : 2010-01-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9259
Submission : 1991-07-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-05
Pay. Date : 2022-11-09
DMF Number : 37631
Submission : 2022-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-24
Pay. Date : 2022-07-13
DMF Number : 31959
Submission : 2017-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-05
Pay. Date : 2015-02-04
DMF Number : 25094
Submission : 2011-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-13
Pay. Date : 2018-07-20
DMF Number : 32090
Submission : 2017-11-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2014-06-15
DMF Number : 28247
Submission : 2014-06-16
Status : Active
Type : II
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