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01 1Gelatin Excipient
02 1Hydroxypropyl Methyl Cellulose
03 1Pullulan
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01 3Active
01 3Blank
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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DMF Number : 35448
Submission : 2020-12-22
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 35449
Submission : 2020-12-30
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 35621
Submission : 2021-02-23
Status : Active
Type : IV