01 2Amoli Organics
02 1Assia Chemical Industries Ltd
03 1Cheng Fong Chemical Co., Ltd
04 1Corden Pharma Bergamo S.p.A
05 1Dipharma
06 2Esteve Quimica
07 1Hainan Poly Pharm
08 1Henan Dongtai Pharma Co Ltd.
09 1Heumann
10 1Hisamitsu Pharmaceutical Co., Inc.
11 1J.B.Chemicals & Pharmaceuticals
12 1Laboratorio Chimico Internazionale Spa
13 1Macleods Pharmaceuticals Limited
14 1Ningbo Smart Pharmaceutical
15 1Syn-Tech Chem. & Pharm
16 1Teva Pharmaceutical Industries
17 2YUNG ZIP CHEMICAL INDUSTRIAL
18 1Yonezawa Hamari Chemicals\
01 12DICLOFENAC SODIUM
02 1DICLOFENAC SODIUM (PROCESS II)
03 1DICLOFENAC SODIUM EP/USP
04 1DICLOFENAC SODIUM EXTENDED RELEASE CAPSULES
05 1DICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE
06 4DICLOFENAC SODIUM USP
07 1HP-5000, TOPICAL PATCH
01 4China
02 1Germany
03 4India
04 2Israel
05 3Italy
06 2Japan
07 2Spain
08 3Taiwan
01 12Active
02 9Inactive
01 10Complete
02 11Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-07-10
DMF Number : 20849
Submission : 2007-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-19
Pay. Date : 2013-06-10
DMF Number : 8192
Submission : 1989-08-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 6689
Submission : 1986-11-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-01
Pay. Date : 2021-06-01
DMF Number : 24580
Submission : 2011-01-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30798
Submission : 2016-11-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 12469
Submission : 1997-04-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-13
Pay. Date : 2014-06-06
DMF Number : 8924
Submission : 1991-01-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18877
Submission : 2005-10-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-03-27
DMF Number : 9899
Submission : 1992-10-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-28
Pay. Date : 2013-01-11
DMF Number : 6981
Submission : 1987-05-27
Status : Active
Type : II
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