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List of Drug Master Files (DMF) of Rilpivirine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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 Cipla
India
CIPLA LTD 37940 RILPIVIRINE 2023-03-16 Active II N/A
26/09/2024 Johnson & Johnson Innovative Medicine
U.S.A
JANSSEN PHARMACEUTICA NV 33713 RILPIVIRINE DRUG SUBSTANCE 2019-04-22 Active II N/A