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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 | Advanced Accelerator Applications |
France |
ADVANCED ACCELERATOR APPLICATIONS USA INC | 31023 | LYSINE HYDROCHLORIDE (HCI)-ARGININE HYDROCHLORIDE (HCI), 2.5%, SOLUTION | 2016-09-26 | Inactive | II | N/A | ||
28/03/2025 | Ajinomoto Company |
Japan |
AJINOMOTO CO INC | 31651 | L-LYSINE MONOHYDROCHLORIDE | 2017-04-20 | Active | II | Complete | 2021-08-27 | 2020-11-30 |