01 2Catalent Pharma Solutions
02 1Cerbios-Pharma SA
03 1DISHMAN NETHERLANDS B.V.
04 1DMFs Not Supported
05 1F. Hoffmann-La Roche
06 1Formosa Laboratories
07 1MicroBiopharm Japan
08 1SAFC
09 1Teva API
10 3Blank
01 11,25-DIHYDROXYCHOLECALCIFEROL
02 11,A,24-DIHYDROXYCHOLECALCIFEROL
03 5CALCITRIOL
04 1CALCITRIOL 0.25 MCG SOFT GELATIN CAPSULES
05 1CALCITRIOL USP
06 1CALCITRIOL, EP
07 1EPI-2010 DRUG SUBSTANCE
08 1ROCALTROL (0.25MCG & 0.5MCG) SOFTGEL CAPSULE
09 1Ro 21-5535 (CALCITRIOL) AMPULS 2.5 mcg/0.5ml
01 1Israel
02 1Japan
03 1Netherlands
04 2Switzerland
05 1Taiwan
06 3U.S.A
07 4Blank
01 5Active
02 8Inactive
01 4Complete
02 9Blank
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 : 2018-04-19
Pay. Date : 2018-03-26
DMF Number : 14093
Submission : 1999-04-16
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3724
Submission : 1980-02-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4093
Submission : 1981-03-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-27
Pay. Date : 2012-12-03
DMF Number : 18227
Submission : 2005-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-01
Pay. Date : 2018-09-25
DMF Number : 15128
Submission : 2000-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12417
Submission : 1997-03-14
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14964
Submission : 2000-07-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6547
Submission : 1986-08-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1889
Submission : 1972-03-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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