01 1Abbott Laboratories
02 2Bracco
03 1Chemi SpA
04 1Divis Laboratories
05 1Hovione
06 1Recordati
07 2UQUIFA
08 1Zambon Group SpA
09 2Zhejiang Starry Pharmaceutical Co., Ltd
01 1(B15000), IOPAMIDOL, BULK FORM
02 5IOPAMIDOL
03 1IOPAMIDOL STEP #1
04 2IOPAMIDOL USP
05 1IOPAMIDOL, USP
06 1PENTAACETYLIOPAMIDOL
07 1PENTAACETYLIOPAMIDOL INTERMEDIATE
01 2China
02 1India
03 5Italy
04 1Portugal
05 2Spain
06 1U.S.A
01 4Active
02 8Inactive
01 3Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10638
Submission : 1993-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3387
Submission : 1978-11-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12229
Submission : 1996-11-13
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-12-17
DMF Number : 18066
Submission : 2005-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11245
Submission : 1994-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12211
Submission : 1996-11-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12279
Submission : 1996-12-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10564
Submission : 1993-10-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-08
Pay. Date : 2022-07-27
DMF Number : 36683
Submission : 2022-01-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-11
Pay. Date : 2014-06-06
DMF Number : 28033
Submission : 2013-12-23
Status : Active
Type : II
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