01 1MSN Laboratories
02 1Zhejiang Yongtai Technology
01 1TERT-BUTYL 2-[(4R,6S)-6-[(E)-2-[4-(4-FLUOROPHENYL)-2-[METHYL (METHYLSULFONYL)AMINO]-6-PROPAN-2-YLPYRIMIDIN-5-YL]ETHENYL]-2,2-DIMETHYL-1,3-DIOXAN-4-YL]ACETATE
02 1TERTIARY BUTYL AMINE SALT OF ROSUVASTATIN [ROUTE CODE - ROC1]
01 1China
02 1India
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23599
Submission : 2010-03-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35320
Submission : 2020-10-28
Status : Active
Type : II
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