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05 Jun 2019
// Andrew McConaghie PMLIVE
http://www.pmlive.com/pharma_news/orkambi_buyers_club_set_up_to_gain_access_to_cheaper_versions_1289916
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16271
Submission : 2002-11-26
Status : Active
Type : II
Certificate Number : R0-CEP 2010-012 - Rev 00
Issue Date : 2011-11-17
Type : Chemical
Substance Number : 1732
Status : Expired

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14504
Submission : 1999-10-22
Status : Active
Type : II
NDC Package Code : 65797-0009
Start Marketing Date : 2025-06-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2026-01-05
Pay. Date : 2025-08-14
DMF Number : 39442
Submission : 2025-09-30
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-05
Pay. Date : 2019-06-11
DMF Number : 20004
Submission : 2006-11-30
Status : Active
Type : II
NDC Package Code : 65797-0002
Start Marketing Date : 2009-12-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23374
Submission : 2009-12-16
Status : Active
Type : II
NDC Package Code : 65797-0006
Start Marketing Date : 2012-04-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22733
Submission : 2009-04-17
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23810
Submission : 2010-05-18
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23350
Submission : 2009-12-08
Status : Inactive
Type : II
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2016-08-24
Registration Number : Number 4554-1-ND(7)
Manufacturer Name : Gador. SA
Manufacturer Address : Calle 10, Fraccion Ⅲ, Parcela 7, Parque Industrial Pilar B1630CFA of the Province of Buenos Aires, Argentine Republic

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17797
Submission : 2004-10-12
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19015
Submission : 2005-12-13
Status : Inactive
Type : II

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Gador SA is a supplier offers 11 products (APIs, Excipients or Intermediates).
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Find a price of CAS 66376-36-1 bulk offered by Gador SA