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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 25898 | PRASUGREL HYDROCHLORIDE | 2012-03-21 | Active | II | Complete | 2013-08-12 | 2013-05-17 |
28/10/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 26951 | PRASUGREL HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) | 2013-03-30 | Active | II | Complete | 2013-08-05 | 2013-03-18 |
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