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XALKORI (crizotinib) Dosage Forms, Composition And Packaging

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Dosage Forms, Composition And Packaging

Dosage Forms

XALKORI (crizotinib) 250 mg capsules: Hard gelatin capsule, size 0, pink opaque/pink opaque, with “Pfizer” on the cap and “CRZ 250” on the body.

XALKORI (crizotinib) 200 mg capsules: Hard gelatin capsule, size 1, white opaque/pink opaque, with “Pfizer” on the cap and “CRZ 200” on the body.

Composition

XALKORI capsules are available in two dosage strengths, 250 mg and 200 mg, containing 250 mg and 200 mg of crizotinib, respectively.

Non-Medicinal Ingredients: Colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, and hard gelatin capsule shells. The pink opaque capsule shell components contain gelatin, titanium dioxide, and red iron oxide. The white opaque capsule shell components contain gelatin and titanium dioxide. The printing ink contains shellac, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.

Packaging

XALKORI is supplied as bottles of 60 and PVC/aluminum foil blisters containing 60 capsules [6 cards of 10 (5 X 2) capsules].

 

Control #: 215123
27 March 2019

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