01 1Aurore Life Sciences
02 1CSPC Pharmaceutical Group
03 1Chemi SpA
04 1EURAND INC
05 1Esteve Quimica
06 1F.I.S. Fabbrica Italiana Sintetici
07 1Genus Lifesciences
08 1Hetero Drugs
09 1Industriale Chimica
10 1Macleods Pharmaceuticals Limited
11 1SIGMA TAU
12 2Blank
01 9INDOMETHACIN
02 1INDOMETHACIN FOR HUMAN USE
03 1INDOMETHACIN USP
04 1INDOMETHACINE USP XX
05 1TIVORBEX (INDOMETHACIN) CAPSULES
01 1China
02 3India
03 3Italy
04 1Spain
05 3U.S.A
06 2Blank
01 5Active
02 8Inactive
01 4Complete
02 9Blank
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-11
Pay. Date : 2022-03-31
DMF Number : 36761
Submission : 2022-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4394
Submission : 1982-01-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21984
Submission : 2008-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4220
Submission : 1981-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5978
Submission : 1985-08-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-07
DMF Number : 3136
Submission : 1978-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-22
Pay. Date : 2021-10-21
DMF Number : 36364
Submission : 2021-10-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2633
Submission : 1976-03-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2021-07-08
DMF Number : 21740
Submission : 2008-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5258
Submission : 1983-07-20
Status : Inactive
Type : II
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