01 1Actavis Inc
02 1Alcami
03 1Apotex Pharmachem
04 1Cipla
05 1Fresenius Kabi AB Brunna
06 1Hetero Drugs
07 1Ind Swift Laboratories Limited
08 1Jiangsu Hengrui Medicine
09 1Mac-Chem Products (India) Pvt.Ltd
10 2Natco Pharma
11 1Olon S.p.A
12 1Sanmar Speciality Chemicals Limited IN 600 086 Chennai
13 1ScinoPharm Taiwan, Ltd
14 1Shilpa Medicare
15 1Sichuan Xieli Pharmaceutical
16 1Sun Pharmaceutical Industries Limited
17 1Tai Heng Industry Co., Ltd
18 1Teva API
19 1Viatris
20 1Zhejiang Hisun Pharmaceutical
21 1Zydus Lifesciences
22 1Blank
01 6LETROZOLE
02 1LETROZOLE (LER)
03 1LETROZOLE DRUG SUBSTANCE
04 12LETROZOLE USP
05 2LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE
06 1LETROZOLE, USP
01 1Canada
02 4China
03 10India
04 1Ireland
05 1Israel
06 1Italy
07 1Sweden
08 1Taiwan
09 2U.S.A
10 1Blank
01 13Active
02 10Inactive
01 7Complete
02 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20566
Submission : 2007-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20175
Submission : 2008-06-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2014-02-07
DMF Number : 24886
Submission : 2011-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22093
Submission : 2008-10-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22812
Submission : 2009-05-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-23
Pay. Date : 2018-02-12
DMF Number : 18388
Submission : 2005-06-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-02
Pay. Date : 2013-06-20
DMF Number : 19139
Submission : 2006-01-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-02
Pay. Date : 2017-12-13
DMF Number : 22632
Submission : 2009-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-18
Pay. Date : 2020-08-12
DMF Number : 21182
Submission : 2007-12-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-18
DMF Number : 20356
Submission : 2007-03-07
Status : Active
Type : II
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