01 1API Corporation
02 1Actavis Inc
03 1Chemi SpA
04 1Divis Laboratories
05 2Erregierre SpA
06 1Esteve Quimica
07 1Hetero Drugs
08 2Ipca Laboratories
09 1Jiangsu Zhongdan Chemical
10 1Lupin Ltd
11 1Napp Technologies
12 2Recordati
13 1Southwest Synthetic Pharmaceutical
14 1Viatris
15 1Zhejiang Shenzhou Pharmaceutical
16 2Blank
01 11NABUMETONE
02 1NABUMETONE (MICRONISED) USP
03 1NABUMETONE DRUG SUBSTANCE
04 5NABUMETONE USP
05 1NABUMETONE USP, PROCESS II
06 1NABUMETONE(BULK)
01 3China
02 5India
03 1Ireland
04 5Italy
05 1Japan
06 1Spain
07 2U.S.A
08 2Blank
01 6Active
02 14Inactive
01 3Complete
02 17Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22258
Submission : 2008-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12296
Submission : 1996-12-23
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-30
Pay. Date : 2015-12-23
DMF Number : 15364
Submission : 2001-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19243
Submission : 2006-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11984
Submission : 1996-06-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-08-01
DMF Number : 26747
Submission : 2012-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12445
Submission : 1997-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-08
Pay. Date : 2013-05-03
DMF Number : 18581
Submission : 2005-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18212
Submission : 2005-03-28
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12091
Submission : 1996-08-13
Status : Inactive
Type : II
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