01 2ALP Pharm
02 2Cerbios-Pharma SA
03 2Chongqing Huapont Pharmaceutical
04 2Formosa Laboratories
05 2Haoyuan Chemexpress Co.Ltd
06 8Leo Pharma
07 1Nanjing Heron Pharmaceutical
08 1SAFC
09 1Teva API
01 1CALCIPOTRIENE
02 1CALCIPOTRIENE (CALCIPOTRIOL)
03 1CALCIPOTRIENE ANHYDROUS
04 1CALCIPOTRIENE CREAM
05 1CALCIPOTRIENE DRUG SUBSTANCE
06 1CALCIPOTRIENE HYDRATE
07 1CALCIPOTRIENE HYDRATE DRUG SUBSTANCE
08 2CALCIPOTRIENE MONOHYDRATE
09 1CALCIPOTRIENE OINTMENT
10 1CALCIPOTRIENE SCALP SOLUTION
11 1CALCIPOTRIENE USP
12 2CALCIPOTRIOL ANHYDROUS
13 2CALCIPOTRIOL MONOHYDRATE
14 1CALCIPOTRIOL SOLUTION CREAM DRUG PRODUCT
15 1CALCIPOTRIOL SUSPENSION CREAM DRUG PRODUCT
16 1FACILITY FOR THE MANUFACTURE OF CALCIPOTRIENE SCALP SOLUTION IN BALLERUP, DENMARK.
17 1INTERMEDIATE OF CALCIPOTRIOL
18 1INTERMEDIATE OF CALCIPOTRIOL (PROCESS II)
01 7China
02 8Denmark
03 1Israel
04 2Switzerland
05 2Taiwan
06 1U.S.A
01 14Active
02 7Inactive
01 5Complete
02 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21943
Submission : 2008-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27222
Submission : 2013-09-06
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 27363
Submission : 2013-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27367
Submission : 2013-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-09-26
DMF Number : 23267
Submission : 2009-11-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-15
Pay. Date : 2013-03-01
DMF Number : 19415
Submission : 2006-05-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10515
Submission : 1993-10-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10514
Submission : 1993-10-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16958
Submission : 2003-11-14
Status : Active
Type : II
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