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Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | HEC Pharm |
China |
RUYUAN HEC PHARM CO LTD | 35343 | ROSUVASTATIN INTERMEDIATE RSV01 | 2020-11-05 | Active | II | N/A | ||
28/10/2024 | MSN Laboratories |
India |
MSN LABORATORIES PRIVATE LTD | 23599 | TERTIARY BUTYL AMINE SALT OF ROSUVASTATIN [ROUTE CODE - ROC1] | 2010-03-02 | Inactive | II | N/A |
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