Assyro AI

Orange Book product · Brand (NDA)

STENDRA

AVANAFIL

Brand (NDA)NDA 202276TE ABRX VIVUS LLC

At a glance

Apr 27, 2012

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 27, 2012

    14 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AVANAFIL

Strength

50MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 202276

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

Agent CTA Background

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