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01 2Beta-Cyclodextrin
02 1Hydroxypropyl Betacyclodextrin
03 1Sulfobutylether-β-Cydodextrin (SBECD)
04 1Blank
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01 5Active
01 1Valid
02 4Blank
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01 5Blank
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01 5Blank
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01 5Blank
01 5Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 29394
Submission : 2015-05-15
Status : Active
Type : IV
Certificate Number : R0-CEP 2021-025 - Rev 00
Issue Date : 2022-06-20
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 37123
Submission : 2022-05-19
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 39021
Submission : 2023-10-21
Status : Active
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 33403
Submission : 2018-12-18
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 42314
Submission : 2025-07-27
Status : Active
Type : IV
