01 1Alkem Laboratories
02 1Apotex Pharmachem
03 2Aurore Life Sciences
04 1Extrovis AG
05 2Hetero Drugs
06 1Jiangsu Hengrui Medicine
07 1Lupin Ltd
08 2MSN Laboratories
09 1Olon S.p.A
10 1Sun Pharmaceutical Industries Limited
11 1Zhejiang Huahai Pharmaceutical
01 10TOLVAPTAN
02 1TOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA]
03 1TOLVAPTAN AMORPHOUS
04 1TOLVAPTAN POVIDONE PREMIX
05 1TOLVAPTAN [ROUTE CODE "TN"]
01 1Canada
02 2China
03 9India
04 1Italy
05 1Switzerland
01 14Active
01 9Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-15
Pay. Date : 2017-10-12
DMF Number : 32030
Submission : 2017-10-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-11
Pay. Date : 2013-11-14
DMF Number : 27636
Submission : 2013-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34316
Submission : 2020-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-05
Pay. Date : 2013-04-26
DMF Number : 27052
Submission : 2013-04-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-06
Pay. Date : 2014-02-26
DMF Number : 27833
Submission : 2014-01-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-18
Pay. Date : 2019-05-10
DMF Number : 32623
Submission : 2019-05-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-30
Pay. Date : 2019-12-10
DMF Number : 28010
Submission : 2014-02-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27808
Submission : 2013-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32717
Submission : 2018-05-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-05-24
DMF Number : 27132
Submission : 2013-05-22
Status : Active
Type : II
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