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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 | Bio-Technology General Israel Ltd. |
Israel |
BIO TECHNOLOGY GENERAL ISRAEL LTD | 20147 | SOMATROPIN (RECOMBINANT HUMAN GROWTH HORMONE) API | 2006-12-31 | Active | II | N/A | ||
28/03/2025 | KREITMAN ROBERT J MD |
U.S.A |
KREITMAN ROBERT J MD | 18630 | INTERLEUKIN-6 PSEUDOMONAS EXOTOXIN FUSION PROTEIN (HUMAN, RECOMBINANT, E. COLI) | 1994-04-06 | Active | II | N/A |