01 1ALP Pharm
02 1Catalent Pharma Solutions
03 1Cerbios-Pharma SA
04 1Formosa Laboratories
05 1Lupin Ltd
06 1Polymed Therapeutics Inc.
07 1Sai Life Sciences Limited
08 1Sun Pharmaceutical Industries Limited
09 1Teva API
10 1Wuxi Fortune Pharmaceutical Co., Ltd
01 6DOXERCALCIFEROL
02 1DOXERCALCIFEROL DRUG SUBSTANCE
03 2DOXERCALCIFEROL USP
04 1HECTOROL 2.5 UG, 1.0 UG, AND 0.5 UG CAPSULES
01 2China
02 3India
03 1Israel
04 1Switzerland
05 1Taiwan
06 2U.S.A
01 7Active
02 3Inactive
01 6Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25148
Submission : 2011-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12838
Submission : 1998-01-29
Status : Inactive
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
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-20
DMF Number : 22136
Submission : 2008-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23233
Submission : 2010-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22590
Submission : 2009-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-25
Pay. Date : 2014-03-10
DMF Number : 22120
Submission : 2008-10-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-01
Pay. Date : 2015-05-22
DMF Number : 25594
Submission : 2012-01-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-04
Pay. Date : 2012-11-08
DMF Number : 15357
Submission : 2001-04-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-11-08
Pay. Date : 2022-07-22
DMF Number : 37132
Submission : 2022-06-20
Status : Active
Type : II
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