01 1Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
02 2Dr. Willmar Schwabe Extracta
03 1Esteve Quimica
04 1Gilead Sciences
05 1Grace
06 1Huzhou Zhanwang Pharmaceutical
07 1MLA Group
08 1Yuhan Corporation
09 4Blank
01 6Active
02 7Blank
01 13Blank
01 1227MF10274
02 12Blank
01 13Blank
01 1Su6273-10-ND
02 1Su6273-11-ND
03 11Blank
01 153499-2911
02 168466-1977
03 187126-015
04 187126-016
05 9Blank
01 13Blank
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GDUFA
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DMF Number : 37722
Submission : 2022-11-25
Status : Active
Type : IV
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DMF Number : 34075
Submission : 2019-08-16
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 41027
Submission : 2024-12-30
Status : Active
Type : IV
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 41165
Submission : 2025-03-03
Status : Active
Type : IV
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GDUFA
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DMF Number : 37871
Submission : 2022-12-16
Status : Active
Type : IV
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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
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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
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 :
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