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List of Drug Master Files (DMF) of AMITRIPTYLINE HCL 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 Dipharma
Italy
DIPHARMA FRANCIS SRL 2908 AMITRIPTYLINE HYDROCHLORIDE 1977-03-18 Active II N/A
26/09/2024 F. Hoffmann-La Roche
Switzerland
KV PHARMACEUTICAL CO 2413 AMITRIPTYLINE HYDROCHLORIDE 1975-03-10 Inactive II N/A