01 25-Methoxyindole-3-Carboxaldehyde
02 1Isosorbide
03 1Isosorbide Dinitrate
04 1Isosorbide Mononitrate
05 1Olsalazine
06 1Pantoprazole Sodium
07 1Pentaerythritol
08 4Blank
01 2Active
02 9Inactive
03 1Blank
01 12Blank
01 1217MF11278
02 11Blank
01 12Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2663
Submission : 1976-05-07
Status : Active
Type : II
Registration Number : 217MF11278
Registrant's Address : Hembrunnstr. 17, CH-5605 Dottikon, Switzerland
Initial Date of Registration : 2005-12-20
Latest Date of Registration :
NDC Package Code : 54864-106
Start Marketing Date : 1983-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20200828-209-J-668(1)
Manufacturer Name : Dottikon Exclusive Synthesis AG
Manufacturer Address : Hembrunnstrasse 17 CH-5605 Dottikon Switzerland
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17677
Submission : 2004-09-13
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15816
Submission : 2002-01-22
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10823
Submission : 1994-03-18
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6789
Submission : 1987-01-23
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16767
Submission : 2003-08-14
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17131
Submission : 2004-01-19
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 : 12320
Submission : 1996-12-30
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 : 15157
Submission : 2000-11-24
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15754
Submission : 2001-12-06
Status : Inactive
Type : II
Dottikon Exclusive Synthesis Ag is a supplier offers 11 products (APIs, Excipients or Intermediates).
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