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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 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 19823 | TAZOBACTAM HEMIHYDRATE USP | 2006-09-27 | Active | II | Complete | 2021-12-16 | 2021-12-13 |
28/03/2025 | Hospira, Inc. |
U.S.A |
PFIZER HEALTHCARE INDIA PVT LTD | 18506 | TAZOBACTAM ACID USP | 2005-07-11 | Inactive | II | N/A |