01 1Croscarmellose Sodium
02 3Microcrystalline Cellulose
03 7Microcrystalline Cellulose API
04 7Blank
01 18Active
01 1Valid
02 17Blank
01 18Blank
01 18Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 20915
Submission : 2007-09-25
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-097 - Rev 01
Issue Date : 2020-12-04
Type :
Substance Number :
Status : Valid
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GDUFA
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DMF Number : 27016
Submission : 2013-03-12
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 32000
Submission : 2017-08-23
Status : Active
Type : IV
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DMF Number : 32001
Submission : 2017-08-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 34895
Submission : 2020-05-27
Status : Active
Type : IV
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DMF Number : 34904
Submission : 2020-06-10
Status : Active
Type : IV
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DMF Number : 35035
Submission : 2020-07-29
Status : Active
Type : IV
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DMF Number : 35036
Submission : 2020-08-03
Status : Active
Type : IV
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DMF Number : 34953
Submission : 2020-07-25
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 : 35311
Submission : 2020-11-14
Status : Active
Type : IV
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