01 1ABX Advanced Biochemical Compounds
02 1Novartis Pharmaceuticals Corporation
03 1piCHEM Forschungs- und Entwicklungs GmbH
01 1Austria
02 1Germany
03 1Switzerland
01 2Active
02 1Inactive
01 3Blank
01 3Blank
01 3Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35060
Submission : 2022-03-16
Status : Active
Type : II
NDC Package Code : 72775-540
Start Marketing Date : 2023-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36829
Submission : 2022-02-28
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
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21869
Submission : 2008-08-08
Status : Inactive
Type : II
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