01 1Taro Pharmaceutical Industries
02 1API Pharma
03 1CML EUROPE BV
04 1Cheminova AS
05 1Henan Tianfu Chemical
06 1PK Chemicals AS
07 1TopChem Pharmaceuticals
01 1China
02 1Croatia
03 1Denmark
04 1India
05 1Ireland
06 2U.S.A
01 3Active
02 2Inactive
03 2Blank
01 1Withdrawn by Holder
02 6Blank
01 7Blank
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23366
Submission : 2010-03-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-06
Pay. Date : 2020-01-13
DMF Number : 34504
Submission : 2020-01-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21045
Submission : 2008-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23897
Submission : 2010-07-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6812
Submission : 1987-01-19
Status : Inactive
Type : II
Certificate Number : R0-CEP 2017-213 - Rev 00
Issue Date : 2019-06-19
Type : Chemical
Substance Number : 1343
Status : Withdrawn by Holder
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