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List of Drug Master Files (DMF) of L-Ornithine-carboxy-14C 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 SIGMA TAU
U.S.A
SIGMA F AND D DIV LTD 4729 L-ORNITHINE HCL 1982-12-02 Inactive II N/A
26/09/2024 Sigma-Aldrich Corporation
U.S.A
SIGMA ALDRICH MANUFACTURING LLC 35111 POLY-L-ORNITHINE HYDROCHLORIDE 2021-01-08 Active II N/A