01 1DZD Heze Pharmaceutical Co Ltd
02 1Intas Pharmaceuticals
03 1Meiji Seika Pharma
04 1MicroBiopharm Japan
05 1Olon S.p.A
06 2Pfizer Inc
07 1RPG Life Sciences Ltd.
08 1Sicor Spa
09 1Sterling Biotech
10 1Synbias Pharma Limited Liability Company
11 1Teva API
12 2Zhejiang Hisun Pharmaceutical
01 1DOXORUBICIN HCL
02 6DOXORUBICIN HYDROCHLORIDE
03 1DOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE
04 2DOXORUBICIN HYDROCHLORIDE USP
05 1DOXORUBICIN HYDROCHLORIDE USP (FERMENTATION)
06 1DOXORUBICIN HYDROCHLORIDE USP/EP
07 1DOXORUBICIN HYDROCHLORIDE(API)
08 1DOXORUBICIN HYDROCHLORIDE, LYOPHILIZED
01 3China
02 3India
03 1Israel
04 2Italy
05 2Japan
06 2U.S.A
07 1Ukraine
01 11Active
02 3Inactive
01 9Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-27
Pay. Date : 2024-07-18
DMF Number : 31153
Submission : 2016-11-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-18
Pay. Date : 2015-12-28
DMF Number : 13209
Submission : 1998-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-25
Pay. Date : 2012-11-13
DMF Number : 13211
Submission : 1998-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-22
Pay. Date : 2018-12-17
DMF Number : 30035
Submission : 2015-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2098
Submission : 1973-04-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24858
Submission : 2011-04-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-14
Pay. Date : 2014-01-28
DMF Number : 16178
Submission : 2002-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-08
DMF Number : 13726
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-07-24
DMF Number : 27311
Submission : 2013-09-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2012-12-18
DMF Number : 13773
Submission : 1998-09-01
Status : Active
Type : II
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