01 1Abiraterone Acetate
02 1Budesonide
03 2Cyproterone Acetate
04 1Dienogest
05 2Dutasteride
06 2Finasteride
07 1Lasmiditan
08 1Levonorgestrel
09 1Medroxyprogesterone Acetate
10 1Mirabegron
11 1Nintedanib Esylate
12 2Oxcarbazepine
13 1Prednisolone
14 2Progesterone
15 1Testosterone
16 1Testosterone Undecanoate
01 18Active
02 3Blank
01 11Valid
02 1Withdrawn by Holder
03 9Blank
01 1230MF10079
02 20Blank
01 4HB230032
02 17Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-27
Pay. Date : 2022-08-04
DMF Number : 25056
Submission : 2011-06-17
Status : Active
Type : II
Certificate Number : R1-CEP 2013-238 - Rev 00
Issue Date : 2020-05-28
Type : Chemical
Substance Number : 1615
Status : Valid
Registration Number : 230MF10079
Registrant's Address : GEDIAN ECONOMIC DEVELOPMENT DISTRICT 436070, E-zhou, Hubei, China
Initial Date of Registration : 2018-07-05
Latest Date of Registration :
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-001
Start Marketing Date : 2012-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140725-94-E-119-10
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.25 Juxian Road, Gedian Economic Development District, E-zhou City, Hubei Province, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-03
Pay. Date : 2022-04-21
DMF Number : 34268
Submission : 2019-10-29
Status : Active
Type : II
Certificate Number : CEP 2019-295 - Rev 02
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 1075
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-004
Start Marketing Date : 2013-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-29
Registration Number : 20210329-209-J-903
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : Gedian Economic Development District, E-zhou City, Hubei Province, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-02
Pay. Date : 2022-08-15
DMF Number : 33000
Submission : 2022-06-24
Status : Active
Type : II
Certificate Number : R0-CEP 2022-199 - Rev 00
Issue Date : 2023-05-19
Type : Chemical
Substance Number : 926
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-012
Start Marketing Date : 2022-03-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
