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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/03/2025 | Sanofi |
France |
RHONE POULENC RORER PHARMACEUTICALS INC | 3316 | ZOPICLONE (26,267 R.P.) | 1978-08-30 | Inactive | II | N/A | ||
| 28/03/2025 | Calyx Chemicals & Pharmaceuticals Limited |
India |
CALYX CHEMICALS AND PHARMACEUTICALS LTD | 15518 | ZOPICLONE E.P. | 2001-06-22 | Active | II | N/A |
