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

GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 37871
Submission : 2022-12-16
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
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
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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
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Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34075
Submission : 2019-08-16
Status : Active
Type : IV

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 :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 87126-015
Start Marketing Date : 2025-10-01
End Marketing Date : 2049-10-01
Dosage Form (Strength) : POWDER, FOR SOLUTION (1g/g)
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 68466-1977
Start Marketing Date : 2020-12-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (620kg 320kg 620kg 620kg 620kg)
Marketing Category : DRUG FOR FURTHER PROCESSING

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

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