01 1Cetostearyl Alcohol
02 2Hydroxyethyl Acrylate
03 5Hypromellose
04 4Mannide Monooleate
05 3Polysorbate 80
06 1Sepitrap 4000
07 1Sorbitan Monolaurate
08 8Blank
01 16Active
02 7Inactive
03 2Blank
01 1Withdrawn by Holder
02 24Blank
01 1221MF20002
02 1223MF20002
03 23Blank
01 25Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24384
Submission : 2010-08-12
Status : Active
Type : IV
Certificate Number : R0-CEP 2000-310 - Rev 02
Issue Date : 2005-03-16
Type :
Substance Number :
Status : Withdrawn by Holder
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18925
Submission : 2005-11-01
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21266
Submission : 2008-01-18
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12524
Submission : 1997-06-02
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14031
Submission : 1999-03-08
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17578
Submission : 2004-07-30
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10870
Submission : 1994-04-14
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22091
Submission : 2008-10-15
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24398
Submission : 2010-09-09
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25438
Submission : 2011-10-25
Status : Active
Type : IV
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