(b) (4) · we also request that you submit the following information: because the dosage strengths...

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Page 1: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,

(b) (4)

(b) (4)

(b) (4)

Page 2: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 3: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 4: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 5: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 6: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 7: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 8: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,

(b) (4)

Page 9: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 10: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 11: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 12: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 13: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,
Page 14: (b) (4) · We also request that you submit the following information: Because the dosage strengths are based on the free base pitavastatin, ... Revise all labeling, where applicable,