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List of Drug Master Files (DMF) of 1-[(2R,4S,5S)-4-azido-5-(hydroxymethyl)oxolan-2-yl]-5-methyl-pyrimidine-2,4-dione Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 208Xls download

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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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 18714 ZIDOVUDINE USP 2005-08-18 Active II Complete 2013-09-21 2013-09-13
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 17638 ZIDOVUDINE USP 2004-08-18 Active II N/A