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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 | Bachem AG |
Switzerland |
BACHEM SA | 9972 | 5-AMINOLEVULINIC ACID HYDROCHLORIDE | 1992-11-25 | Active | II | N/A | ||
28/03/2025 | Heraeus Holding |
Germany |
HERAEUS PRECIOUS METALS GMBH AND CO KG | 24359 | 5-AMINOLEVULINIC ACID HYDROCHLORIDE | 2010-11-12 | Active | II | N/A |