01 1Clarochem Ireland
02 2Dasami Lab
03 1Lupin Ltd
04 1MSN Laboratories
05 1Piramal Pharma Solutions
06 1Quimica Sintetica
07 1Sumitomo Pharma
08 1Sun Pharmaceutical Industries Limited
09 1Viatris
01 9DROXIDOPA
02 1DROXIDOPA (PROCESS-II)
01 5India
02 1Ireland
03 1Japan
04 1Spain
05 2U.S.A
01 9Active
02 1Inactive
01 8Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-20
Pay. Date : 2019-01-31
DMF Number : 33459
Submission : 2019-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-10
Pay. Date : 2020-11-25
DMF Number : 35368
Submission : 2020-11-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-02
Pay. Date : 2017-11-08
DMF Number : 32184
Submission : 2017-12-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2017-10-17
DMF Number : 32032
Submission : 2017-10-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-12
Pay. Date : 2017-10-10
DMF Number : 31514
Submission : 2017-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-25
Pay. Date : 2019-12-31
DMF Number : 34258
Submission : 2019-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-08
Pay. Date : 2017-12-06
DMF Number : 32264
Submission : 2017-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20556
Submission : 2007-05-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34389
Submission : 2019-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-15
Pay. Date : 2018-08-22
DMF Number : 33089
Submission : 2018-09-18
Status : Active
Type : II
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