01 1ALPS Pharmaceutical Ind. Co. Ltd.
02 1Amphastar Pharmaceuticals
03 1Biochem Corporation JP 350-0814 Saitama
04 1GLAND PHARMA LIMITED
05 1Reliable Biopharmaceutical Corporation
06 2Yuki Gosei Kogyo
07 1Blank
01 6PROTAMINE SULFATE
02 2PROTAMINE SULFATE USP
01 1India
02 4Japan
03 2U.S.A
04 1Blank
01 5Active
02 3Inactive
01 4Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-18
Pay. Date : 2018-09-27
DMF Number : 20538
Submission : 2007-05-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-19
Pay. Date : 2022-10-11
DMF Number : 30429
Submission : 2016-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14973
Submission : 2000-07-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-23
Pay. Date : 2021-12-14
DMF Number : 36568
Submission : 2021-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19008
Submission : 2005-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-11
Pay. Date : 2012-11-28
DMF Number : 15421
Submission : 2000-01-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4626
Submission : 1982-07-30
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41932
Submission : 2025-05-28
Status : Active
Type : II
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