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01 2TATM
02 1Water-18O
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01 2Active
02 1Inactive
01 1Valid
02 2Blank
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01 3Blank
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01 3Blank
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01 3Blank
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01 161704-001
02 2Blank
01 3Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21130
Submission : 2007-12-07
Status : Inactive
Type : II
Certificate Number : CEP 2011-287 - Rev 03
Issue Date : 2025-01-14
Type : Chemical
Substance Number : 2294
Status : Valid
NDC Package Code : 61704-001
Start Marketing Date : 2014-01-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22823
Submission : 2009-05-29
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 : 19758
Submission : 2006-09-06
Status : Active
Type : II