01 1Aurobindo Pharma Limited
02 1Fuxin Long Rui Pharmaceutical
03 1Hetero Drugs
04 1JILIN ASYMCHEM LABORATORIES CO LTD
05 1KOLON Life Science, Inc
06 1Kowa India
07 2Lupin Ltd
08 1MSN Laboratories
09 2Nissan Chemical
10 1Solara Active Pharma Sciences
11 1Viatris
12 1Wanbang Biopharmaceuticals
13 1Zhejiang Hisun Pharmaceutical
14 1Zydus Lifesciences
01 1NK-104 TABLETS
02 11PITAVASTATIN CALCIUM
03 1PITAVASTATIN CALCIUM (ASYMMETRIC SYNTHESIS METHOD)
04 1PITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE)
05 1PITAVASTATIN CALCIUM (PENTAHYDRATE)
06 1PITAVASTATIN SODIUM
01 3China
02 8India
03 2Japan
04 1South Korea
05 2U.S.A
01 13Active
02 3Inactive
01 9Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-05-07
DMF Number : 27106
Submission : 2013-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-10
DMF Number : 27255
Submission : 2013-07-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-31
Pay. Date : 2015-11-12
DMF Number : 29650
Submission : 2015-11-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-07-08
DMF Number : 27242
Submission : 2013-07-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-03-28
DMF Number : 23488
Submission : 2010-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14660
Submission : 2000-01-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27761
Submission : 2013-12-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-30
DMF Number : 25956
Submission : 2012-04-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-19
Pay. Date : 2013-06-18
DMF Number : 27144
Submission : 2013-06-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-29
DMF Number : 27333
Submission : 2013-07-31
Status : Active
Type : II
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