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01 1(6S)-5-METHYLTETRAHYDROFOLIC ACID CALCIUM SALT
02 1CALCIPOTRIENE ANHYDROUS
03 1CALCIPOTRIENE MONOHYDRATE
04 1CALCITRIOL
05 1CALCIUM LEVOFOLINATE
06 1DOXERCALCIFEROL
07 1LEUCOVORIN CALCIUM
08 1LEVOFOLINIC ACID CRYSTALLINE
09 1TIOTROPIUM BROMIDE
10 1TIOTROPIUM BROMIDE MONOHYDRATE
01 10CERBIOS PHARMA SA
01 10Switzerland
01 10Active
01 8Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-31
DMF Number : 26016
Submission : 2012-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-05
Pay. Date : 2013-06-26
DMF Number : 23103
Submission : 2009-09-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-13
Pay. Date : 2016-08-31
DMF Number : 30615
Submission : 2016-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2012-12-18
DMF Number : 14718
Submission : 2000-02-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 23437
Submission : 2010-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-25
Pay. Date : 2014-07-29
DMF Number : 28353
Submission : 2014-07-03
Status : Active
Type : II
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