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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 | Ono Pharmaceutical |
Japan |
MARUISHI PHARMACEUTICAL CO LTD | 27130 | ALPROSTADIL ALFADEX | 2013-04-26 | Active | II | N/A | ||
28/03/2025 | Ono Pharmaceutical |
Japan |
ONO PHARMACEUTICAL CO LTD | 10415 | ALPROSTADIL ALFADEX I.V. | 1993-08-10 | Inactive | II | N/A |