LORBRENA 6 Dosage Forms, Strengths, Composition And Packaging

lorlatinib

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Table – Dosage Forms, Strengths, Composition and Packaging
Route of Administration	Dosage Form / Strength/Composition	Non-medicinal Ingredients
Oral	Film-coated tablet 25 mg, 100 mg	Tablet core contains: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate Film-coating contains: ferrosofferic oxide/Black iron oxide, hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, iron oxide red, lactose monohydrate, macrogol/polyethylene glycol (PEG) 3350, titanium dioxide, triacetin

Description

25 mg: 8 mm round tan immediate release film-coated tablet, debossed with “Pfizer” on one side and “25” and “LLN” on the other side.

100 mg: oval (17 x 8.5 mm) lavender immediate release film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side.

Packaging: LORBRENA is supplied as follows:
25 mg

high density polyethylene bottles containing 30, 60, or 100 tablets
aluminum foil blisters with aluminum foil backing containing 120 tablets (12 cards of 10 tablets)

100 mg

high density polyethylene bottles containing 30, 60, or 100 tablets
aluminum foil blisters with aluminum foil backing containing 30 tablets (3 cards of 10 tablets)

)

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6 Dosage Forms, Strengths, Composition And Packaging

Table – Dosage Forms, Strengths, Composition and Packaging
Route of Administration	Dosage Form / Strength/Composition	Non-medicinal Ingredients
Oral	Film-coated tablet 25 mg, 100 mg	Tablet core contains: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate Film-coating contains: ferrosofferic oxide/Black iron oxide, hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, iron oxide red, lactose monohydrate, macrogol/polyethylene glycol (PEG) 3350, titanium dioxide, triacetin

Description

25 mg: 8 mm round tan immediate release film-coated tablet, debossed with “Pfizer” on one side and “25” and “LLN” on the other side.

100 mg: oval (17 x 8.5 mm) lavender immediate release film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side.

Packaging: LORBRENA is supplied as follows:
25 mg

high density polyethylene bottles containing 30, 60, or 100 tablets
aluminum foil blisters with aluminum foil backing containing 120 tablets (12 cards of 10 tablets)

100 mg

high density polyethylene bottles containing 30, 60, or 100 tablets
aluminum foil blisters with aluminum foil backing containing 30 tablets (3 cards of 10 tablets)

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