01 3ACS DOBFAR SPA
02 1Aurobindo Pharma Limited
03 1CSPC Pharmaceutical Group
04 1CordenPharma
05 1Fermenta Biotech Limited
06 1Fresenius Kabi AB Brunna
07 1GSK
08 1Sandoz B2B
01 1China
02 1Germany
03 2India
04 3Italy
05 1Sweden
06 1Switzerland
07 1United Kingdom
01 4Active
02 5Inactive
03 1Blank
01 10Blank
01 10Blank
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22473
Submission : 2009-01-29
Status : Active
Type : II
NDC Package Code : 65862-500
Start Marketing Date : 2024-01-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (48kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13695
Submission : 1998-09-01
Status : Active
Type : II
NDC Package Code : 52946-0819
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2021-07-27
Registration Number : 20210708-210-J-1060(1)
Manufacturer Name : ACS DOBFAR SPA
Manufacturer Address : Via Rossini, 7/9/11 20067 Tribiano Milano Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-10
Pay. Date : 2015-05-26
DMF Number : 27313
Submission : 2013-10-08
Status : Active
Type : II
NDC Package Code : 52946-0819
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2021-07-27
Registration Number : 20210708-210-J-1060(1)
Manufacturer Name : ACS DOBFAR SPA
Manufacturer Address : Via Rossini, 7/9/11 20067 Tribiano Milano Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-03
Pay. Date : 2013-12-17
DMF Number : 25387
Submission : 2011-09-01
Status : Active
Type : II
NDC Package Code : 66558-0202
Start Marketing Date : 2011-05-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13653
Submission : 1998-09-01
Status : Inactive
Type : II
NDC Package Code : 61126-704
Start Marketing Date : 2011-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (13kg/13kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19696
Submission : 2006-08-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13387
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13697
Submission : 1998-09-01
Status : Inactive
Type : II
NDC Package Code : 52946-0819
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2021-07-27
Registration Number : 20210708-210-J-1060(1)
Manufacturer Name : ACS DOBFAR SPA
Manufacturer Address : Via Rossini, 7/9/11 20067 Tribiano Milano Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13554
Submission : 1998-09-01
Status : Inactive
Type : II
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