01 2ACS DOBFAR SPA
02 1Ajanta Pharma Limited
03 1Aurobindo Pharma Limited
04 1Bristol Myers Squibb
05 1China Union Chempharma (Suzhou) Co.,Ltd
06 1CordenPharma
07 1Grand Health Industrial Co Ltd
08 1Hikma Pharmaceuticals
09 1Lupin Ltd
10 1Orchid Pharma
11 1Qilu Pharmaceutical
12 2RANBAXY LABORATORIES LIMITED
13 1Sneha Medicare Pvt Ltd
14 1TAPI Technology & API Services
15 3Blank
01 3China
02 1Germany
03 7India
04 1Israel
05 2Italy
06 1U.S.A
07 1United Kingdom
08 3Blank
01 5Active
02 10Inactive
03 4Blank
01 3Valid
02 1Withdrawn by Holder
03 15Blank
01 19Blank
01 1WC-0048
02 1WC-0120
03 1WC-0131
04 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13225
Submission : 1998-04-30
Status : Active
Type : II
NDC Package Code : 52946-0903
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2012-03-16
Registration Number : 20050831-19-A-11-02(6)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 7/9 20871 Vimercate (MB)-Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8391
Submission : 1990-01-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13745
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14308
Submission : 1999-07-22
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14201
Submission : 1999-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13638
Submission : 1998-09-01
Status : Inactive
Type : II
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