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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 | ALP Pharm |
China |
ALP PHARM BEIJING CO LTD | 23997 | POLYMYXIN B SULFATE USP | 2010-07-02 | Active | II | N/A | ||
28/03/2025 | BIOTIKA a.s. |
Slovakia |
BIOTIKA AS | 23876 | POLYMYXIN B SULFATE | 2010-05-31 | Active | II | Complete | 2014-09-29 | 2013-12-11 |