01 2Apicore LLC
02 1Auro Peptides Limited
03 1Fresenius Kabi Anti-Infectives
04 1Hansoh Pharma
05 1Hybio Pharmaceutical
06 1Lianyungang Runzhong Pharmaceutical Co Ltd
07 1Shenzhen JYMed Technology
01 1DEGARELIX
02 2DEGARELIX ACETATE
03 1DEGARELIX ACETATE MANNITOL PREMIX 29% (STERILE)
04 1DEGARELIX ACETATE MANNITOL PREMIX 45% (STERILE)
05 1DEGARELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE
06 1DEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCE
07 1DEGARELIX ACETATE, NON-STERILE, BULK DRUG SUBSTANCE
01 4China
02 3India
03 1Italy
01 8Active
01 5Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37113
Submission : 2023-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37005
Submission : 2023-04-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-08
Pay. Date : 2020-08-07
DMF Number : 35078
Submission : 2020-08-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-27
Pay. Date : 2022-12-05
DMF Number : 36499
Submission : 2023-01-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-24
Pay. Date : 2021-09-17
DMF Number : 36216
Submission : 2022-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38904
Submission : 2023-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-08
Pay. Date : 2020-10-19
DMF Number : 35257
Submission : 2020-10-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-09
Pay. Date : 2019-03-01
DMF Number : 33550
Submission : 2019-02-21
Status : Active
Type : II
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