01 1Cipla
02 1Hetero Drugs
03 1Johnson & Johnson Innovative Medicine
04 1Laurus Labs
05 1MSN Laboratories
06 1Reyoung pharmaceutical
07 1Shanghai Desano Bio-Pharmaceutical
08 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
09 1Viatris
01 7RILPIVIRINE HYDROCHLORIDE
02 1RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE
03 1RILPIVIRINE HYDROCHLORIDE [ROUTE CODE RC]
01 3China
02 4India
03 2U.S.A
01 8Active
02 1Inactive
01 6Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-04
Pay. Date : 2019-07-29
DMF Number : 30773
Submission : 2017-01-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-11
Pay. Date : 2015-09-24
DMF Number : 29301
Submission : 2015-04-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-12-26
DMF Number : 23824
Submission : 2010-07-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-15
Pay. Date : 2015-11-02
DMF Number : 29841
Submission : 2015-12-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-04
Pay. Date : 2018-03-07
DMF Number : 30423
Submission : 2016-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37479
Submission : 2022-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26305
Submission : 2012-08-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39552
Submission : 2024-02-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-30
Pay. Date : 2013-07-08
DMF Number : 27253
Submission : 2013-07-24
Status : Active
Type : II
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