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Orange Book product · Generic (ANDA)

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Generic (ANDA)ANDA 091211TE ABRX GLENMARK PHARMS LTD

At a glance

Apr 06, 2015

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 06, 2015

    11 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Strength

62.5MG;25MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 091211

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ATOVAQUONE; PROGUANIL HYDROCHLORIDE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.