01 1Acebright India Pharma Private Limited
02 1Arene Lifesciences
03 1Aurobindo Pharma Limited
04 1Catalent Pharma Solutions
05 1Cipla
06 3Hetero Drugs
07 1Laurus Labs
08 1MATRIX LABORATORIES XIAMEN LTD.
09 1RANBAXY LABORATORIES LIMITED
10 2Shanghai Desano Chemical Pharmaceutical Co., Ltd.
11 2Viatris
01 1LOPINAVIR
02 1LOPINAVIR (LOR)
03 1LOPINAVIR (LVR)
04 1LOPINAVIR (PROCESS-II)
05 1LOPINAVIR AMORPHOUS
06 1LOPINAVIR HYDRATE
07 5LOPINAVIR USP
08 1LOPINAVIR USP (NON STERILE DRUG SUBSTANCE)
09 1LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)]
10 1LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES
11 1Lopinavir Drug Substance
01 3China
02 9India
03 3U.S.A
01 11Active
02 4Inactive
01 5Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28244
Submission : 2014-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19862
Submission : 2006-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-15
Pay. Date : 2013-09-20
DMF Number : 27462
Submission : 2013-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-18
Pay. Date : 2016-06-23
DMF Number : 30636
Submission : 2016-07-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2013-04-04
DMF Number : 26303
Submission : 2012-08-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2013-01-24
DMF Number : 19852
Submission : 2006-10-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-11
Pay. Date : 2019-06-10
DMF Number : 33919
Submission : 2019-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34144
Submission : 2019-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30154
Submission : 2015-12-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20363
Submission : 2007-05-30
Status : Active
Type : II
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