01 2Seratec SAS
02 1Siegfried AG
01 2France
02 1Switzerland
01 3Active
01 2Valid
02 1Blank
01 3Blank
01 3Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34783
Submission : 2020-05-25
Status : Active
Type : II
Certificate Number : R0-CEP 2020-226 - Rev 00
Issue Date : 2022-02-11
Type : Chemical
Substance Number : 1971
Status : Valid
NDC Package Code : 65732-131
Start Marketing Date : 2021-01-29
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 : 35574
Submission : 2021-01-29
Status : Active
Type : II
NDC Package Code : 65732-131
Start Marketing Date : 2021-01-29
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 : 4038
Submission : 1981-01-20
Status : Active
Type : II
Certificate Number : R1-CEP 2002-028 - Rev 01
Issue Date : 2009-03-30
Type : Chemical
Substance Number : 1971
Status : Valid
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