01 1Aurore Life Sciences
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1HONOUR LAB LTD
04 1MSN Laboratories
05 1Optimus Pharma
06 1SMS Pharmaceuticals
07 1Shandong Luxi Pharmaceutical Co.,Ltd.
01 7MOLNUPIRAVIR
01 2China
02 5India
01 7Active
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36329
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 37435
Submission : 2022-08-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36282
Submission : 2021-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35960
Submission : 2021-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2021-06-28
DMF Number : 36078
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37087
Submission : 2022-05-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36770
Submission : 2022-07-15
Status : Active
Type : II
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