01 1Emcure Pharmaceuticals
02 1Heraeus Holding
03 1IDT Australia Limited
04 1Indena
05 1Jiangsu Hengrui Medicine
06 1MSN Laboratories
07 1Natco Pharma
08 1SEACROSS PHARMACEUTICALS
09 1Teva API
10 1Viatris
11 3Blank
01 6THIOTEPA
02 4THIOTEPA USP
03 1THIOTEPA USP NON STERILE BULK DRUG
04 1THIOTEPA USP XX
05 1THIOTEPA USP [ROUTE CODE "ZT"]
01 1Australia
02 1China
03 1Germany
04 3India
05 1Israel
06 1Italy
07 1U.S.A
08 1United Kingdom
09 3Blank
01 7Active
02 6Inactive
01 3Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32746
Submission : 2018-06-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-01
Pay. Date : 2014-10-15
DMF Number : 13911
Submission : 1998-12-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14170
Submission : 1999-06-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33037
Submission : 2019-05-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-12
Pay. Date : 2017-10-10
DMF Number : 30424
Submission : 2016-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-08
Pay. Date : 2019-01-28
DMF Number : 31104
Submission : 2017-05-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38406
Submission : 2023-08-15
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8228
Submission : 1989-09-26
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7518
Submission : 1988-06-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5396
Submission : 1984-06-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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