01 1CKD Bio Corporation
02 1Gujarat Themis Biosyn
03 1Luohe Chief Pharmaceutical
04 2Luohe Nanjiecun Pharmac. Group Pharmacy
05 2Lupin Ltd
06 2Olon S.p.A
01 1RIFAMYCIN O
02 1RIFAMYCIN O, NON-STERILE API
03 2RIFAMYCIN S
04 1RIFAMYCIN S (PURIFIED)
05 1RIFAMYCIN S (RODANO SITE)
06 1RIFAMYCIN S (SETTIMO SITE)
07 1RIFAMYCIN-O
08 1RIFAMYCIN-S (BULK SUBSTANCE)
01 3China
02 3India
03 2Italy
04 1South Korea
01 9Active
01 9Blank
GDUFA
DMF Review : N/A
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DMF Number : 26159
Submission : 2012-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 38988
Submission : 2023-10-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35703
Submission : 2021-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35707
Submission : 2021-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28546
Submission : 2014-07-25
Status : Active
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 22325
Submission : 2008-12-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11291
Submission : 1995-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32722
Submission : 2018-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32708
Submission : 2018-05-07
Status : Active
Type : II
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