Source: FDA, National Drug Code (US) Revision Year: 2020
The active ingredient in DOPTELET is avatrombopag maleate, a thrombopoietin receptor agonist. The chemical name of avatrombopag maleate is 4-piperidinecarboxylic acid, 1-[3-chloro-5-[[[4-(4-chloro-2-thienyl)5(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-2-pyridinyl]-, (2Z)-2-butenedioate (1:1). It has the molecular formula C29H34Cl2N6O3S2· C4H4O4. The molecular weight is 765.73.
The structural formula is:
The aqueous solubility of avatrombopag maleate at various pH levels indicates that the drug substance is practically insoluble at pH 1 to 11.
DOPTELET is provided as an immediate-release tablet. Each DOPTELET tablet contains 20 mg avatrombopag (equivalent to 23.6 mg of avatrombopag maleate) and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Coating film: polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide and ferric oxide yellow.
| Dosage Forms and Strengths |
|---|
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Tablets: 20 mg as round, biconvex, yellow, film-coated tablets debossed with “AVA” on one side and “20” on the other side. |
| How Supplied |
|---|
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DOPTELET 20 mg tablets are supplied as round, biconvex, yellow, film-coated tablets, and debossed with “AVA” on one side and “20” on the other side. NDC 71369-020-10: carton of one blister card with 10 tablets. NDC 71369-020-15: carton of one blister card with 15 tablets. NDC 71369-020-30: carton of two blister cards with 15 tablets (30 tablets total). |
| Drug | Countries | |
|---|---|---|
| DOPTELET | Austria, Estonia, Spain, Finland, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom, United States |
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