01 2BASF
02 1DISHMAN NETHERLANDS B.V.
03 1DMFs Not Supported
04 1Dishman Carbogen Amcis
05 2F. Hoffmann-La Roche
06 1Fermenta Biotech Limited
07 2Polymed Therapeutics Inc.
08 3Royal DSM
09 1SAFC
10 2SOLVAY -Technology Solutions
11 2Supreem Pharmaceuticals Mysore Pvt Ltd
12 1Zhejiang Garden Biochemical High-tech
13 1Blank
01 11A-HYDROXY VITAMIN D3
02 11a,25-DIHYDROXYCHOLECALCIFEROL (RO21,5535) IN USAN IS CALCITRIOL
03 12-METHYLENE-19-NOR-20-EPI-1A, 25-DIHYDDROXYVITAMIN D3
04 125-HYDROXY-CHOLECALCIFEROL
05 3CHOLECALCIFEROL
06 2CHOLECALCIFEROL (VITAMIN D3)
07 1CHOLECALCIFEROL CONCENTRATE (POWDER FORM) DRUG SUBSTANCE
08 1CHOLECALCIFEROL CRYSTAL (NON-STERILE BULK DRUG SUBSTANCE)
09 1CHOLECALCIFEROL USP
10 1CHOLECALCIFEROL USP (CRYSTALLINE VITAMIN D3)
11 1Cholecalciferol (Vitamin D3)
12 1DRY VITAMIN D3 100
13 1DRY VITAMIN D3 50
14 1LIQUID VITAMIN D3 IN CORN OIL
15 1RO 21-5816/000 24R,25-DIHYDROXYCHOLECALCIFEROL
16 1VITAMIN D3 (CHOLECALCIFEROL) WATER SOLUBLE 100 IU/MG
17 1VITAMIN D3 STABILIZED 20 IU/MG
01 1China
02 4Germany
03 4India
04 4Netherlands
05 2Switzerland
06 3U.S.A
07 2Blank
01 10Active
02 10Inactive
01 1Complete
02 19Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17421
Submission : 2004-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21380
Submission : 2008-02-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25584
Submission : 2011-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20524
Submission : 2007-05-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19489
Submission : 2006-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-11
Pay. Date : 2017-01-10
DMF Number : 30832
Submission : 2016-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21048
Submission : 2007-11-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37963
Submission : 2023-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32699
Submission : 2018-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23749
Submission : 2010-04-20
Status : Active
Type : II
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