01 1Bismuth Subcitrate Potassium
02 1Mafenide
03 1Sodium Phenylbutyrate
01 3Active
01 3Blank
01 3Blank
01 3Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-07
Pay. Date : 2014-06-13
DMF Number : 28358
Submission : 2014-06-11
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 : 24722
Submission : 2011-03-08
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 : 25560
Submission : 2011-12-22
Status : Active
Type : II
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