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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 | Boehringer Ingelheim GmbH |
Germany |
BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | 5441 | HOMATROPINE METHYLBROMIDE | 1984-05-24 | Inactive | II | N/A | ||
28/03/2025 | C-Squared Pharma |
Ireland |
C-SQUARED PHARMA LTD | 31086 | HOMATROPINE METHYLBROMIDE USP | 2016-12-16 | Active | II | Complete | 2017-05-15 | 2017-01-03 |