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01 1ACESULFAME POTASSIUM USP
02 1BETADEX USP
03 1CROSCARMELLOSE SODIUM USP
04 1DICOM-DC PL005 CO-PROCESSED DIRECT COMPRESSION EXCIPIENT
05 1DICOM-DC SP204
06 1DICOM-DC SP205
07 1DICOM-DC SP206
08 1DICOM-DC SR300 CO-PROCESSED DIRECT COMPRESSION EXCIPIENT
09 1GELLETS-P MICROCRYSTALLINE CELLULOSE PELLETS
10 1HYDROXYPROPYL BETADEX
11 1MICROLOSE M60 (CO-PROCESSED LACTOSE MONOHYDRATE AND MICROCRYSTALLINE CELLULOSE)
12 1PROBLEND - SILICIFIED MICROCRYSTALLINE CELLULOSE
13 1SODIUM STARCH GLYCOLATE USP
14 1SODIUM STEARYL FUMARATE USP EXCIPIENT
15 1STARLOSE CO-PROCESSED GRANULATED DIRECT COMPRESSION EXCIPIENT
16 1SUCRALOSE USP
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39527
Submission : 2024-02-08
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39536
Submission : 2024-02-14
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37534
Submission : 2022-09-27
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 34087
Submission : 2019-08-19
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 33656
Submission : 2019-03-13
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33609
Submission : 2019-02-26
Status : Active
Type : IV
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