01 1Kyowa Kirin
02 1MSN Laboratories
03 1Procos
04 1Blank
01 3ISTRADEFYLLINE
02 1ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE
01 1India
02 1Italy
03 1Japan
04 1Blank
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23936
Submission : 2010-07-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38721
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38212
Submission : 2023-04-12
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40030
Submission : 2024-07-09
Status : Active
Type : II
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