01 1Glycerine
02 1Medium Chain Triglycerides Excipient
03 1Propylene Glycol
04 4Blank
01 7Active
01 7Blank
01 7Blank
01 7Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 32997
Submission : 2018-10-26
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 718
Submission : 1963-10-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 12805
Submission : 1997-12-15
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 720
Submission : 1963-10-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 1529
Submission : 1970-05-20
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 11214
Submission : 1994-11-30
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19346
Submission : 2006-04-07
Status : Active
Type : IV
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