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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 | Kyowa Hakko Bio |
Japan |
KYOWA HAKKO KOGYO CO LTD | 2753 | L-CYSTINE & DERIVATIVE L-CYSTINE HCL & N-ACETYL-L-CYSTEIN | 1976-10-15 | Inactive | II | N/A | ||
| 28/03/2025 | Mitsubishi Tanabe Pharma |
Japan |
TANABE SEIYAKU CO LTD | 1930 | L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE | 1972-05-09 | Inactive | II | N/A |
