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01 1CAS No 1613220-15-7
02 1Elexacaftor
03 2Enavogliflozin
04 1Exatecan
05 1Ivacaftor
06 1Mafodotin [Usan]
07 1Monomethyl Auristatin E
08 1Roxadustat
09 1Sparsentan
10 1Telotristat Etiprate
11 1Tezacaftor
12 1Tirzepatide
13 1Zanubrutinib
14 15Blank
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01 6Active
02 12Inactive
03 11Blank
01 29Blank
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01 29Blank
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01 29Blank
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01 1Su171-4-ND
02 1Su171-4-ND(1)
03 1Su248-16-ND
04 1Su969-1-ND
05 25Blank
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01 124538-021
02 124538-208
03 124538-311
04 124538-445
05 124538-599
06 124538-606
07 124538-661
08 124538-770
09 21Blank
01 29Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37610
Submission : 2023-06-07
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 : 36725
Submission : 2022-02-03
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 : 36104
Submission : 2021-07-22
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-24
Pay. Date : 2021-04-14
DMF Number : 34821
Submission : 2020-05-29
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 : 38725
Submission : 2023-08-16
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 : 40431
Submission : 2024-08-29
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 32693
Submission : 2019-01-02
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 33124
Submission : 2018-12-28
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 : 37861
Submission : 2022-12-28
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 : 37862
Submission : 2022-12-28
Status : Inactive
Type : II

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