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Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0002-4184

Application Number

NDA020815

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 19, 2023

Ingredients

Code: 4F86W47BR6Class: ACTIBQuantity: 60 mg in 1 1

Carnauba WaxInactive

Code: R12CBM0EIZClass: IACT

Crospovidone, UnspecifiedInactive

Code: 2S7830E561Class: IACT

Lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Povidone, UnspecifiedInactive

Code: FZ989GH94EClass: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

Anhydrous lactoseInactive

Code: 3SY5LH9PMKClass: IACT

Polyethylene glycol 400Inactive

Code: B697894SGQClass: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

Propylene glycolInactive

Code: 6DC9Q167V3Class: IACT