01 2Carboxymethyl Ether
02 1Croscarmellose Sodium
03 1Dextrose Monohydrate
04 1Dibasic Calcium Phosphate
05 1Hypromellose
06 1Hypromellose, Unspecified
07 1Maltodextrin Excipient
08 8Microcrystalline Cellulose
09 1Sodium Alginate Excipient
10 1Sodium Stearyl Fumarate
11 5Blank
01 17Active
02 4Inactive
03 2Blank
01 3Valid
02 20Blank
01 1218MF20002
02 22Blank
01 23Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 34780
Submission : 2020-07-09
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-169 - Rev 00
Issue Date : 2021-06-03
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 6410
Submission : 1986-06-10
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-321 - Rev 01
Issue Date : 2014-08-07
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 24809
Submission : 2011-03-31
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 11051
Submission : 1994-08-01
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 24926
Submission : 2011-05-04
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 11198
Submission : 1994-11-11
Status : Active
Type : IV
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DMF Number : 11963
Submission : 1996-05-09
Status : Active
Type : IV
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DMF Number : 12150
Submission : 1996-10-04
Status : Active
Type : IV
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DMF Number : 17835
Submission : 2004-11-17
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 12549
Submission : 1997-06-07
Status : Active
Type : IV
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