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List of Drug Master Files (DMF) of 2-Butanol, 4-(dimethylamino)-3-methyl-1,2-diphenyl-, propionate (ester), hydrochloride, (+)- 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 AAIPharma Services Corp.
U.S.A
AAI PHARMA LLC 5430 PROPOXYPHENE HCL BULK & INTERMEDIATE PRODUCED BY TIPPECANOE LABS 1984-07-03 Inactive II N/A
26/09/2024 AAIPharma Services Corp.
U.S.A
AAI PHARMA LLC 4886 PROPOXYPHENE HCL 1983-03-16 Inactive II N/A