duloxetine

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit