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01 1Calcium Acid Phosphate
02 1Mannitol
03 2Microcrystalline Cellulose
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01 4Active
01 4Blank
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01 4Blank
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01 4Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 40121
Submission : 2024-06-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 39756
Submission : 2024-03-27
Status : Active
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 34186
Submission : 2019-10-13
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 39283
Submission : 2023-12-14
Status : Active
Type : IV