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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Acebright India Pharma Private Limited |
India |
CYDMAX INDIA PHARMA PRIVATE LTD | 27143 | TENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)] | 2013-05-08 | Active | II | Complete | 2017-07-26 | 2016-09-23 |
24/02/2025 | Aurisco Pharmaceutical |
China |
AURISCO PHARMACEUTICAL CO LTD | 30730 | TENOFOVIR DISOPROXIL FUMARATE | 2016-07-25 | Active | II | Complete | 2017-03-31 | 2016-07-25 |