01 1Avesta Pharma
02 1Jiahua Chemical
03 1SASOL GERMANY GMBH
04 1The Dow Chemical Company
05 1Tianjin Bokelin Pharmaceutical Packaging
06 3Union Carbide Corporation
07 1Blank
01 2Active
02 7Blank
01 4Valid
02 5Blank
01 9Blank
01 9Blank
01 9Blank
01 159044-0007
02 159044-0017
03 159044-0027
04 6Blank
01 9Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-418 - Rev 00
Issue Date : 2025-03-26
Type : Chemical
Substance Number : 1444
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2006-085 - Rev 04
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
Status : Valid
NDC Package Code : 59044-0017
Start Marketing Date : 2018-06-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2009-392 - Rev 01
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Status : Valid
NDC Package Code : 59044-0007
Start Marketing Date : 2006-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (22.7kg/22.7kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59044-0027
Start Marketing Date : 2006-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (907kg/907kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2016-283 - Rev 01
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Status : Valid
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