01 1Exopharm
02 1Pfizer Inc
03 1Sicor Spa
04 2Synbias Pharma Limited Liability Company
05 1TAPI Technology & API Services
06 1Zhejiang Hisun Pharmaceutical
01 1IDARUBICIN AGLYCONE (BULK CHEMICAL)
02 1IDARUBICIN HCL
03 3IDARUBICIN HYDROCHLORIDE
04 1IDARUBICIN HYDROCHLORIDE USP
05 1IDARUBICIN HYDROCHLORIDE, USP NON-STERILE BULK DRUG SUBSTANCE
01 1Australia
02 1China
03 1Israel
04 1Italy
05 1U.S.A
06 2Ukraine
01 3Active
02 4Inactive
01 3Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19185
Submission : 2006-02-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16057
Submission : 2002-07-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13876
Submission : 1998-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-15
Pay. Date : 2022-05-31
DMF Number : 36526
Submission : 2021-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17504
Submission : 2004-06-26
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-08
DMF Number : 13884
Submission : 1998-12-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-11-26
DMF Number : 19613
Submission : 2006-07-17
Status : Active
Type : II
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