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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 | Aurobindo Pharma Limited |
India |
AUROBINDO PHARMA LTD | 19851 | INDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE) | 2006-10-06 | Inactive | II | N/A | ||
28/03/2025 | Viatris |
U.S.A |
MYLAN LABORATORIES LTD | 18495 | INDINAVIR SULFATE USP | 2005-07-12 | Inactive | II | N/A |