Orange Book product · Brand (NDA)

MALARONE

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Brand (NDA)NDA 021078TE ABRX GLAXOSMITHKLINE

View ATOVAQUONE; PROGUANIL HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Jul 14, 2000

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jul 14, 2000
26 yr 4 mo ago
Today

Pharmaceutical detail

Active ingredient

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Strength

250MG;100MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021078

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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