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01 12Decamethylcyclopentasiloxane
02 1Dimethicone
03 1Hydroxypropyl Methyl Cellulose
04 1Hypromellose Acetate Succinate
05 7Ion Exchange Resins
06 1Methyl Cellosolve
07 1Methylcellulose
08 3Polyethylene Glycol 3350
09 4Polyethylene Glycol 4000
10 1Polyethylene Glycol Excipient
11 1Polyethylene Oxide
12 6Silicon
13 1Simethicone
14 19Blank
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01 19Active
02 32Inactive
03 8Blank
01 1Valid
02 2Withdrawn by Holder
03 56Blank
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01 1219MF10061
02 1229MF10139
03 1303MF10091
04 56Blank
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01 59Blank
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01 120210517-211-J-832
02 120210517-211-J-832(1)
03 57Blank
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01 159044-0005
02 159044-0007
03 159044-0015
04 159044-0017
05 159044-0025
06 159044-0027
07 53Blank
01 59Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1499
Submission : 1970-03-06
Status : Active
Type : IV
Registration Number : 303MF10091
Registrant's Address : 974 Center Road, Wilmington, DE 19805, USA
Initial Date of Registration : 2021-06-07
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 76
Submission : 1950-03-10
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-006 - Rev 01
Issue Date : 2011-01-05
Type :
Substance Number :
Status : Withdrawn by Holder

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1870
Submission : 1971-10-20
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-007 - Rev 01
Issue Date : 2011-06-24
Type :
Substance Number :
Status : Withdrawn by Holder

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 126
Submission : 1954-02-09
Status : Inactive
Type : IV
Registration Number : 219MF10061
Registrant's Address : 974 Center Road, Wilmington, DE 19805, USA
Initial Date of Registration : 2007-03-05
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17718
Submission : 2004-09-30
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12903
Submission : 1998-03-10
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18443
Submission : 2005-06-21
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1891
Submission : 1971-07-21
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12220
Submission : 1996-10-31
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17213
Submission : 2004-03-01
Status : Active
Type : IV

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