01 1BETA CYCLODEXTRIN
02 1CROSCARMELLOSE SODIUM (CRESTCROSS)
03 1DIBASIC CALCIUM PHOSPHATE (CRESTADD)
04 1EXPLOTAB BRAND OF SODIUM STARCH GLYCOLATE
05 1GLYCOLYS@SODIUM STARCH GLYCOLATE NF
06 1GLYCOLYS® SODIUM STARCH GLYCOLATE USP/NF
07 1HYDROXY-PROPYL BETA-CYCLODEXTRIN
08 1LYCASIN BRAND HYDROGENATED GLUCOSE SYRUP(LYCASIN HGS
09 1LYCASIN BRAND OF HYDROGENATED GLUCOSE SYRUP
10 1MAGNESIUM STEARATE (LUBRICREST)
11 1MALTODEXTRIN FOR PERITONEAL DIALYSIS
12 1MANNITOL USP POWDER PEARLITOL ®
13 1MANNITOL, SPRAY DRIED
14 1MICROCEL MICROCRYSTALLINE CELLULOSE
15 1MICROCRYSTALLINE CELLULOSE (CELLUCREST)
16 1NEOSORB 70/20 SORBITOL SOLUTION
17 1PEA STARCH HYDROXYPROPYL (LYCOAT r NG)
18 1PEARLITOL FLASH
19 1POLYSORB 85/70/00 (SORBITOL SORBITAN SOLUTION)
20 1PREGELATINIZED HYDROXYPROPYL PEA STARCH (LYCOAT ® RS)
21 1PREGELATINIZED MAIZE STARCH (GELMAC)
22 1SODIUM STARCH GLYCOLATE (RAPIGEL)
23 1SOLUTAB CROSCARMELLOSE SODIUM
24 1TABULOSE SC, MICROCRYSTALLINE CELLULOSE AND CARBOXYMETHYLCELLULOSE SODIUM
01 4CREST CELLULOSE PRIVATE LIMITED
02 2CREST CELLULOSE PRIVATE LTD
03 4ITACEL FARMOQUIMICA LTDA
04 1ROQUETTE AMERICA INC
05 1ROQUETTE CORPORATION
06 11ROQUETTE FRERES
07 1ROQUETTE NATIONAL CHIMIE OF LILLE
01 1Brazil
02 22France
03 1U.S.A
01 19Active
02 5Inactive
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9155
Submission : 1991-06-10
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32790
Submission : 2018-04-27
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31776
Submission : 2017-05-19
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3495
Submission : 1979-03-16
Status : Inactive
Type : II
Excipients Web Link
