Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ACS DOBFAR SPA
03 1Akzo Nobel Polymer Chem LLC
04 1HILL DERMACEUTICALS INC
05 1Henan Lihua Pharmaceutical
06 1Pfizer Inc
07 1Sicor Spa
08 2Teva API
09 1Blank
01 1DERMA-SMOOTHE CAPSULES
02 1DIHYDROFLUOCINOLONE ACETONIDE
03 1FLUOCINOLONE 16,17 ACETONIDE & FLUOCINOLONE
04 4FLUOCINOLONE ACETONIDE
05 1FLUOCINOLONE ACETONIDE (PROCESS I)
06 1FLUOCINOLONE ACETONIDE - PROCESS II
07 1FLUOCINOLONE ACETONIDE 1,2-DIHYDRO
01 1China
02 1Germany
03 2Israel
04 2Italy
05 3U.S.A
06 1Blank
01 4Active
02 6Inactive
01 3Complete
02 7Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-16
Pay. Date : 2013-05-07
DMF Number : 17395
Submission : 2004-05-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2787
Submission : 1976-11-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2944
Submission : 1977-05-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40406
Submission : 2024-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6503
Submission : 1986-07-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16086
Submission : 2002-08-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15572
Submission : 2001-07-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-23
Pay. Date : 2013-10-09
DMF Number : 4486
Submission : 1982-04-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2012-11-08
DMF Number : 23875
Submission : 2010-06-09
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5365
Submission : 1984-05-14
Status : Inactive
Type : II
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