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01 1DEXTROSE MONOHYDRATE USP GRADE (LYCADEX® PF)
02 1DEXTROSE MONOHYDRATE, USP GRADE
03 1HYDROXYPROPYL BETADEX
04 1MANNITOL
05 1MANNITOL GRANULAR G.G.
06 1MANNITOL USP GRADE (PEARLITOL PF)
07 1MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN LESTREM,FRANCE.
08 1ROQUETTE® POLYDEXTRIN (Icodextrin)
09 1SODIUM GLUCONATE
10 1SODIUM STARCH GLYOLATE LOW PH
11 1SORBITOL POWDER PYROGEN FREE
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01 1ROQUETTE AMERICA INC
02 10ROQUETTE FRERES
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01 11France
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01 7Active
02 4Inactive
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01 4Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-01
Pay. Date : 2014-04-29
DMF Number : 4697
Submission : 1982-10-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-23
Pay. Date : 2015-01-05
DMF Number : 11059
Submission : 1994-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 30897
Submission : 2016-08-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5443
Submission : 1984-06-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 6650
Submission : 1986-10-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-07-22
DMF Number : 12879
Submission : 1998-02-26
Status : Active
Type : II