01 1Aciclovir
02 1CAS 330786-24-8
03 1Clopidogrel
04 1Dextromethorphan Hydrobromide
05 1Diphenhydramine Hydrochloride
06 2Dipyridamole
01 4Active
02 2Inactive
03 1Blank
01 1Valid
02 6Blank
01 1221MF10089
02 1222MF10071
03 5Blank
01 7Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34995
Submission : 2020-08-06
Status : Active
Type : II
Certificate Number : R0-CEP 2020-035 - Rev 00
Issue Date : 2022-08-03
Type : Chemical
Substance Number : 1199
Status : Valid
Registration Number : 222MF10071
Registrant's Address : No. 268 SHANGHAI RD. BINJIANG FINE CHEMICAL INDUSTRY ZONE, QIDONG CITY, JIANGSU PROVINCE, CHINA
Initial Date of Registration : 2010-02-25
Latest Date of Registration :
NDC Package Code : 68166-003
Start Marketing Date : 2019-10-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 31447
Submission : 2017-02-07
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 27836
Submission : 2013-12-12
Status : Active
Type : II
NDC Package Code : 68166-004
Start Marketing Date : 2019-10-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 22290
Submission : 2008-12-08
Status : Active
Type : II
NDC Package Code : 68166-001
Start Marketing Date : 2019-10-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2017-09-07
Registration Number : 20170907-211-J-3
Manufacturer Name : Qidong Dongyue Pharmaceutical Co., Ltd
Manufacturer Address : No.268 Shanghai Rd., Binjiang Fine Chemical Industry Zone, Qidong City, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 221MF10089
Registrant's Address : HEHE TOWN, QIDONG CITY, JIANGSU PROVINCE, CHINA
Initial Date of Registration : 2009-05-13
Latest Date of Registration :
NDC Package Code : 68166-003
Start Marketing Date : 2019-10-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 26659
Submission : 2012-04-25
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 : 24959
Submission : 2011-05-02
Status : Inactive
Type : II
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