01 1Abiogen Pharma S.p.A
02 1Olon S.p.A
03 1Patheon
04 1Sifavitor srl
01 3Italy
02 1U.S.A
01 1Active
02 3Blank
01 2Valid
02 2Blank
01 4Blank
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24598
Submission : 2011-01-21
Status : Active
Type : II
Certificate Number : CEP 2018-078 - Rev 04
Issue Date : 2024-08-30
Type : Chemical
Substance Number : 1777
Status : Valid
Certificate Number : R1-CEP 2011-060 - Rev 00
Issue Date : 2018-06-13
Type : Chemical
Substance Number : 1777
Status : Valid
NDC Package Code : 17337-0510
Start Marketing Date : 2020-03-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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