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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
29/01/2026 Arch Pharmalabs
India
ARCH PHARMALABS LTD 24069 ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL-6-CYANOMETHYL-2,2-DIMETHYL-1,3-DIOXANE-4-ACETATE 2011-01-12 Active II N/A