01 2Amoli Organics
02 1Amsa Spa
03 1Assertio Therapeutics
04 1COSMA S.p.A
05 2J.B.Chemicals & Pharmaceuticals
06 1YUNG ZIP CHEMICAL INDUSTRIAL
01 1DICLOFENAC
02 2DICLOFENAC ACID
03 1DICLOFENAC DIETHYAMINE
04 1DICLOFENAC DIETHYLAMINE
05 2DICLOFENAC HYDROXY ETHYL PYRROLIDINE
06 1ZORVOLEX® (DICLOFENAC) CAPSULES
01 4India
02 2Italy
03 1Taiwan
04 1U.S.A
01 8Active
01 2Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23680
Submission : 2010-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-12
Pay. Date : 2014-05-19
DMF Number : 28208
Submission : 2014-04-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14831
Submission : 2000-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26224
Submission : 2012-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27322
Submission : 2014-03-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-11
Pay. Date : 2014-09-04
DMF Number : 15366
Submission : 2001-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19020
Submission : 2006-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25107
Submission : 2011-06-30
Status : Active
Type : II
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