01 1CAS 53-16-7
02 1Desogestrel
03 1Dienogest
04 1Estriol
05 1Ethinyl Estradiol
06 1Gestodene
07 1Heparin Sodium
08 3Levonorgestrel
09 1Mifepristone
10 1Sulfamethoxazole
11 1Testosterone
12 1Tibolone
01 7Active
02 7Blank
01 8Valid
02 1Withdrawn by Holder
03 5Blank
01 1231MF10019
02 13Blank
01 14Blank
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 : 29345
Submission : 2015-06-08
Status : Active
Type : II
Certificate Number : R1-CEP 2015-160 - Rev 00
Issue Date : 2022-01-19
Type : Chemical
Substance Number : 1726
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22222
Submission : 2008-11-24
Status : Active
Type : II
Registration Number : 231MF10019
Registrant's Address : No. 97,Zhuzhou Road,Laoshan Area,Qingdao,China
Initial Date of Registration : 2019-01-29
Latest Date of Registration :
NDC Package Code : 42455-001
Start Marketing Date : 2005-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (140[USP'U]/140[USP'U])
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27692
Submission : 2013-10-20
Status : Active
Type : II
Certificate Number : R0-CEP 2022-225 - Rev 00
Issue Date : 2022-12-20
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 44132-004
Start Marketing Date : 2012-06-08
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 :
Pay. Date :
DMF Number : 29217
Submission : 2015-03-26
Status : Active
Type : II
Certificate Number : R1-CEP 2015-015 - Rev 00
Issue Date : 2021-02-11
Type : Chemical
Substance Number : 1739
Status : Valid
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2014-03-07
Registration Number : 20140306-140-H-248-03
Manufacturer Name : Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
Manufacturer Address : No.10, Longhai Road, Economic & Technological Development Zone, Qinhuangdao, Hebei, PRChina
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28304
Submission : 2014-05-13
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2015-219 - Rev 00
Issue Date : 2021-09-08
Type : Chemical
Substance Number : 1717
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28680
Submission : 2014-09-25
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2015-014 - Rev 00
Issue Date : 2021-02-11
Type : Chemical
Substance Number : 1203
Status : Valid
NDC Package Code : 44132-007
Start Marketing Date : 2012-08-06
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
Certificate Number : R1-CEP 2011-220 - Rev 01
Issue Date : 2020-08-25
Type : Chemical
Substance Number : 140
Status : Valid
NDC Package Code : 44132-002
Start Marketing Date : 2012-05-30
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
Certificate Number : R1-CEP 2013-237 - Rev 00
Issue Date : 2019-04-30
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 44132-004
Start Marketing Date : 2012-06-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
China Resources Zizhu Pharmaceutical is a supplier offers 1 products (APIs, Excipients or Intermediates).
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