Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Bayer AG
03 1Gedeon Richter
04 1Industriale Chimica
05 1Lupin Ltd
06 2NEWCHEM SPA
07 1Sterling Spa
08 1Sun Pharmaceutical Industries Limited
09 1Teva API
01 4DROSPIRENONE
02 1DROSPIRENONE EP/USP
03 5DROSPIRENONE USP
01 1Germany
02 1Hungary
03 3India
04 1Israel
05 4Italy
01 10Active
01 6Complete
02 4Blank
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32885
Submission : 2018-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12138
Submission : 1996-09-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17866
Submission : 2004-12-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-31
Pay. Date : 2018-05-03
DMF Number : 20676
Submission : 2007-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-26
DMF Number : 23397
Submission : 2010-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-07
Pay. Date : 2022-01-25
DMF Number : 36709
Submission : 2022-01-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-04
Pay. Date : 2012-11-27
DMF Number : 22802
Submission : 2009-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-08
Pay. Date : 2013-04-24
DMF Number : 21733
Submission : 2008-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23580
Submission : 2010-08-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 22878
Submission : 2009-06-18
Status : Active
Type : II
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