01 1Apotex Pharmachem
02 1Aurisco Pharmaceutical
03 1Hetero Drugs
04 2Industriale Chimica
05 1MSN Laboratories
06 1Zhejiang Shenzhou Pharmaceutical
01 3EPLERENONE
02 1EPLERENONE API
03 1EPLERENONE MEK HEMISOLVATE (1:0.5)
04 1EPLERENONE PH. EUR.
05 1EPLERENONE [ROUTE CODE: PL]
01 1Canada
02 2China
03 2India
04 2Italy
01 6Active
02 1Inactive
01 4Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19796
Submission : 2006-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-30
Pay. Date : 2013-12-02
DMF Number : 27672
Submission : 2013-12-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-16
Pay. Date : 2019-09-24
DMF Number : 33832
Submission : 2019-05-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-15
Pay. Date : 2019-01-29
DMF Number : 32998
Submission : 2018-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19715
Submission : 2006-09-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-14
Pay. Date : 2013-12-04
DMF Number : 23466
Submission : 2010-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37024
Submission : 2022-07-13
Status : Active
Type : II
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