GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37722
Submission : 2022-11-25
Status : Active
Type : IV

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 : 41027
Submission : 2024-12-30
Status : Active
Type : IV

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 41165
Submission : 2025-03-03
Status : Active
Type : IV

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37871
Submission : 2022-12-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34075
Submission : 2019-08-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 932
Submission : 1965-12-16
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 87126-016
Start Marketing Date : 2025-12-01
End Marketing Date : 2049-12-01
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Registration Number : 227MF10274
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2015-12-01
Latest Date of Registration :

Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2016-07-01
Registration Number : Su6273-11-ND
Manufacturer Name : Esteve Quimica, SA
Manufacturer Address : C/ Ter, 94 Polígon Industrial 17460 Celrà (Girona), Spain

Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2016-07-01
Registration Number : Su6273-10-ND
Manufacturer Name : Yuhan Chemical
Manufacturer Address : 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do

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