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List of Drug Master Files (DMF) of Excipients submissions by Silverline Chemical to the U.S. FDA. Original Data : FDA Website

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01 1BENZYL BENZOATE USP/BP

02 1CAMPHOR EP/BP/USP/JP

03 1CASTOR OIL BP/EP/USP/JP/DAB/IP

04 1CROSCARMELLOSE SODIUM USP/BP/EP/IP/JP

05 1DL-MENTHOL USP/IP/JP

06 1LEVO-MENTHOL USP/BP/EP/IP/JP

07 1PEPPERMINT OIL USP/BP/EP/IP/JP

08 1SODIUM STARCH GLYCOLATE USP/BP/EP/IP/JP

09 1THYMOL USP/BP/EP/IP/JP

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09

LEVO-MENTHOL USP/BP/EP/IP/JP

AAPS 2024
Not Confirmed
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LEVO-MENTHOL USP/BP/EP/IP/JP

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AAPS 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32331

Submission : 2018-02-12

Status : Active

Type : IV

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