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01 1Aluminium Monostearate
02 1Calcium Carbonate Excipient
03 1Calcium Hydroxide
04 1Calcium Stearate
05 1Calcium Stearate API
06 1Calsil
07 1Dextrose
08 1Kaolin Excipient
09 1Magnesium Hydroxide Excipient
10 1Magnesium Stearate
11 1Silicon Dioxide
12 1Stearic Acid
13 1Talc
14 1Zinc Carbonate
15 1Zinc Oxide Excipient
16 1Zinc Stearate
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01 16Active
01 16Blank
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01 16Blank
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01 16Blank
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01 16Blank
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01 16Blank
01 16Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 37646
Submission : 2022-11-05
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 35106
Submission : 2020-08-26
Status : Active
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 35102
Submission : 2020-08-26
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 35100
Submission : 2020-08-26
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 35101
Submission : 2020-08-26
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 29612
Submission : 2015-06-25
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 37656
Submission : 2022-11-05
Status : Active
Type : IV
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DMF Number : 35103
Submission : 2020-08-26
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Number : 35104
Submission : 2020-08-26
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 : 35105
Submission : 2020-08-26
Status : Active
Type : IV