01 3ABX Advanced Biochemical Compounds
02 1DMFs Not Supported
03 1Eckert & Ziegler Strahlen
04 1GE Healthcare Inc
05 1IRE Elit
06 1Isotope Technologies Munich
01 1Belgium
02 5Germany
03 1United Kingdom
04 1Blank
01 5Active
02 3Inactive
01 8Blank
01 8Blank
01 8Blank
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GDUFA
DMF Review : N/A
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DMF Number : 33682
Submission : 2019-04-30
Status : Active
Type : II
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DMF Number : 28741
Submission : 2014-10-13
Status : Active
Type : II
GDUFA
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DMF Number : 34938
Submission : 2020-07-10
Status : Active
Type : II
GDUFA
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DMF Number : 31715
Submission : 2017-03-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 33795
Submission : 2019-09-19
Status : Active
Type : II
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GDUFA
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DMF Number : 36825
Submission : 2022-03-04
Status : Inactive
Type : II
GDUFA
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DMF Number : 36826
Submission : 2022-03-04
Status : Inactive
Type : II
GDUFA
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DMF Number : 3752
Submission : 1980-03-10
Status : Inactive
Type : II
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