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01 1Mannitol
02 1Mannitol API
03 1Sodium Alginate
04 1Sodium Alginate Excipient
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01 4Active
01 1Valid
02 3Blank
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01 4Blank
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01 4Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39554
Submission : 2024-02-25
Status : Active
Type : IV
Certificate Number : CEP 2023-334 - Rev 00
Issue Date : 2025-01-02
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41483
Submission : 2025-03-21
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41485
Submission : 2025-03-21
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42440
Submission : 2025-09-08
Status : Active
Type : IV
