01 1Cytarabine
02 1Fasudil Hydrochloride Hydrate
03 1Omidenepag Isopropyl
04 1Tranexamic Acid
05 1Ubidecarenone
06 1Uracil Mustard
07 1Blank
01 2Active
02 3Inactive
03 2Blank
01 2Valid
02 5Blank
01 1217MF10811
02 1218MF10210
03 1228MF10198
04 1229MF10105
05 3Blank
01 7Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-30
Pay. Date : 2017-06-08
DMF Number : 6215
Submission : 1986-01-23
Status : Active
Type : II
Certificate Number : CEP 2017-218 - Rev 03
Issue Date : 2024-09-20
Type : Chemical
Substance Number : 760
Status : Valid
Registration Number : 217MF10811
Registrant's Address : 3-3-23 Nakanoshima, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration :
NDC Package Code : 12848-1003
Start Marketing Date : 1986-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Handok Co., Ltd.
Registration Date : 2022-07-13
Registration Number : 20220713-210-J-1332
Manufacturer Name : Asahi Kasei Finechem Co., Ltd. Nobeoka Pharmaceuticals Plant
Manufacturer Address : 6-2633-7 Asahimachi, Nobeoka, Miyazaki 882-0847, Japan
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-20
Pay. Date : 2018-12-11
DMF Number : 25331
Submission : 2011-09-14
Status : Active
Type : II
Certificate Number : R1-CEP 2008-186 - Rev 01
Issue Date : 2020-05-05
Type : Chemical
Substance Number : 875
Status : Valid
Registration Number : 218MF10210
Registrant's Address : 3-3-23 Nakanoshima, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2006-02-16
Latest Date of Registration :
NDC Package Code : 12848-1004
Start Marketing Date : 1972-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 229MF10105
Registrant's Address : 3-3-23 Nakanoshima, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2017-06-21
Latest Date of Registration :
NDC Package Code : 12848-1006
Start Marketing Date : 2022-12-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.1kg/.1kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Santen Pharmaceutical Co., Ltd.
Registration Date : 2019-12-03
Registration Number : 4272-4-ND
Manufacturer Name : Asahi Kasei Finechem Co., Ltd. Nobeoka Pharmaceuticals Plant
Manufacturer Address : 6-2633-7 Asahi-machi, Nobeoka City, Miyazaki, Japan
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 228MF10198
Registrant's Address : 1-5-1 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2016-10-19
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15639
Submission : 2001-09-21
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 : 20532
Submission : 2007-05-10
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 : 9908
Submission : 1992-10-14
Status : Inactive
Type : II
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