TALZENNA 6 Dosage Forms, Strengths, Composition And Packaging

talazoparib

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Table 3– Dosage Forms, Strengths, Composition and Packaging.
Route of AdministrationDosage Form / Strength/CompositionNon-medicinal Ingredients
Oral

Capsule

0.25 mg: Each capsule contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base. 
 

1 mg: Each capsule contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.

Silicified microcrystalline cellulose

0.25 mg capsule shell: hypromellose, titanium  
dioxide, yellow iron oxide.  
1 mg capsule shell: hypromellose, red iron oxide, titanium dioxide, yellow iron oxide. Printing ink: ammonium hydroxide, black iron oxide, potassium hydroxide, propylene glycol, shellac.

TALZENNA 0.25 mg capsules  
Opaque, size #4 hard hypromellose (HPMC) capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).

TALZENNA 1 mg capsules  
Opaque, size #4 hard hypromellose (HPMC) capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).

)

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6 Dosage Forms, Strengths, Composition And Packaging

Table 3– Dosage Forms, Strengths, Composition and Packaging.
Route of AdministrationDosage Form / Strength/CompositionNon-medicinal Ingredients
Oral

Capsule

0.25 mg: Each capsule contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base. 
 

1 mg: Each capsule contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.

Silicified microcrystalline cellulose

0.25 mg capsule shell: hypromellose, titanium  
dioxide, yellow iron oxide.  
1 mg capsule shell: hypromellose, red iron oxide, titanium dioxide, yellow iron oxide. Printing ink: ammonium hydroxide, black iron oxide, potassium hydroxide, propylene glycol, shellac.

TALZENNA 0.25 mg capsules  
Opaque, size #4 hard hypromellose (HPMC) capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).

TALZENNA 1 mg capsules  
Opaque, size #4 hard hypromellose (HPMC) capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).

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