01 1Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
02 1Gilead Sciences
03 1Grace
04 1Huzhou Zhanwang Pharmaceutical
05 1MLA Group
06 1Schwabe North America
07 1Schwabe Pharma
08 1Blank
01 5Active
02 3Blank
01 8Blank
01 1227MF10274
02 7Blank
01 8Blank
01 8Blank
01 153499-2911
02 168466-1977
03 6Blank
01 8Blank
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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 :
Pay. Date :
DMF Number : 34075
Submission : 2019-08-16
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 : 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 : 932
Submission : 1965-12-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37871
Submission : 2022-12-16
Status : Active
Type : IV
NDC Package Code : 68466-1977
Start Marketing Date : 2020-12-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (620kg 320kg 620kg 620kg 620kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 53499-2911
Start Marketing Date : 2020-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (620kg 320kg 620kg 620kg 620kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
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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