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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
26/09/2024 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 34294 | INDACATEROL MALEATE | 2019-12-31 | Active | II | N/A | ||
26/09/2024 | Breathgreen Pharmaceuticals |
U.S.A |
BREATHGREEN PHARMACEUTICAL CO LTD | 39765 | INDACATEROL MALEATE(MICRONIZED AND NON-MICRONIZED) | 2024-03-25 | Active | II | N/A |
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