01 1GE Healthcare Inc
02 1HUAYI ISOTOPE CO
03 2Rotem Industries
01 1China
02 2Israel
03 1United Kingdom
01 3Active
02 1Inactive
01 2Valid
02 2Blank
01 4Blank
01 4Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22823
Submission : 2009-05-29
Status : Active
Type : II
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21089
Submission : 2007-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36900
Submission : 2022-04-01
Status : Active
Type : II
Certificate Number : CEP 2022-176 - Rev 00
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 2294
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21130
Submission : 2007-12-07
Status : Inactive
Type : II
Certificate Number : R1-CEP 2011-287 - Rev 02
Issue Date : 2023-04-27
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
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