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01 2Cornstarch
02 1Hydroxyethyl Starch
03 5Lactulose
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01 3Active
02 1Inactive
03 4Blank
01 7Valid
02 1Blank
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01 8Blank
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01 120220622-210-J-1318
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01 118124-007
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-09
Pay. Date : 2014-12-12
DMF Number : 15253
Submission : 2001-02-16
Status : Active
Type : II
Certificate Number : R1-CEP 2005-023 - Rev 02
Issue Date : 2017-09-07
Type : Chemical
Substance Number : 924
Status : Valid
NDC Package Code : 18124-007
Start Marketing Date : 2022-05-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1250kg/1250kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-25
Pay. Date : 2012-11-28
DMF Number : 15254
Submission : 2001-02-16
Status : Active
Type : II
Certificate Number : R1-CEP 2002-236 - Rev 03
Issue Date : 2017-10-11
Type : Chemical
Substance Number : 1230
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-22
Pay. Date : 2017-01-23
DMF Number : 20562
Submission : 2007-05-29
Status : Active
Type : II
Certificate Number : R1-CEP 2015-187 - Rev 00
Issue Date : 2020-10-30
Type : Chemical
Substance Number : 924
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22328
Submission : 2008-12-20
Status : Inactive
Type : II
Certificate Number : CEP 2019-138 - Rev 01
Issue Date : 2024-08-27
Type : Chemical
Substance Number : 924
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-242 - Rev 00
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-284 - Rev 00
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 1998-130 - Rev 03
Issue Date : 2007-11-30
Type : Chemical
Substance Number : 924
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2022-06-22
Registration Number : 20220622-210-J-1318
Manufacturer Name : Fresenius Kabi Austria GmbH
Manufacturer Address : Estermannstraße 17, 4020 Linz, Austria
Fresenius Kabi Austria is a supplier offers 4 products (APIs, Excipients or Intermediates).
Find a price of Lactulose bulk with DMF, CEP offered by Fresenius Kabi Austria
Find a price of Lactulose bulk with CEP offered by Fresenius Kabi Austria
Find a price of Cornstarch bulk with CEP offered by Fresenius Kabi Austria
Find a price of Hydroxyethyl Starch bulk offered by Fresenius Kabi Austria