01 1Cardinal Health
02 1EASTMAN KODAK
03 1Macco Organiques Inc
04 2Macco Organiques, Spol. s.r o
05 1Merck Group
06 1Niacet b.v
07 1Quality Chemicals
08 1Siemens Molecular Imaging
09 1Sudeep Pharma
10 1Tomita Pharmaceutical
11 1Vasa Pharmachem
01 1Canada
02 2Czech Republic
03 2Germany
04 2India
05 1Japan
06 1Spain
07 3U.S.A
01 1Active
02 5Inactive
03 6Blank
01 12Blank
01 1305MF10045
02 11Blank
01 12Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-29
Pay. Date : 2019-10-30
DMF Number : 27844
Submission : 2013-12-20
Status : Active
Type : II
NDC Package Code : 55897-001
Start Marketing Date : 2012-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8132
Submission : 1989-07-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24560
Submission : 2011-01-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31926
Submission : 2017-10-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6654
Submission : 1986-10-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26352
Submission : 2012-08-24
Status : Inactive
Type : II
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