01 1Auro Peptides Limited
02 1CordenPharma
03 1GLAND PHARMA LIMITED
04 1Hybio Pharmaceutical
05 1TAPI Technology & API Services
01 1CO-POLYMER-1 (COP-1)
02 3GLATIRAMER ACETATE
03 1GLATIRAMER ACETATE, NON-STERILE BULK DRUG SUBSTANCE
01 1China
02 1Germany
03 2India
04 1Israel
01 4Active
02 1Inactive
01 3Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-08
Pay. Date : 2020-12-24
DMF Number : 35493
Submission : 2020-12-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-05
Pay. Date : 2013-11-22
DMF Number : 27723
Submission : 2013-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33092
Submission : 2018-09-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-07
Pay. Date : 2018-02-09
DMF Number : 28989
Submission : 2014-12-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7609
Submission : 1988-08-02
Status : Inactive
Type : II
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