01 1F. Hoffmann-La Roche
02 1Kyowa Pharma Chemical Co Ltd
03 1Shanghai Ziyuan Pharmaceutical
04 1Valens Molecules
05 1Zhejiang Jiuzhou Pharmaceutical
06 3Blank
01 2China
02 1India
03 1Japan
04 1Switzerland
05 3Blank
01 2Active
02 5Inactive
03 1Blank
01 1Valid
02 7Blank
01 8Blank
01 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15646
Submission : 2001-08-13
Status : Active
Type : II
NDC Package Code : 65344-0011
Start Marketing Date : 2023-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13073
Submission : 1998-07-07
Status : Active
Type : II
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 : 2483
Submission : 1975-07-14
Status : Inactive
Type : II
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 : 3491
Submission : 1979-01-30
Status : Inactive
Type : II
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 : 8152
Submission : 1989-08-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 687
Submission : 1963-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5995
Submission : 1985-08-13
Status : Inactive
Type : II
Certificate Number : R0-CEP 2019-210 - Rev 00
Issue Date : 2021-10-27
Type : Chemical
Substance Number : 2741
Status : Valid
NDC Package Code : 62705-0225
Start Marketing Date : 2022-03-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6534
Submission : 2023-07-06
Status : Active
Type : II
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