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Orange Book product · Generic (ANDA)

ENTECAVIR

ENTECAVIR

Generic (ANDA)ANDA 208195TE ABRX YUNG SHIN PHARM
View ENTECAVIR familyOpen on FDA Orange Book

At a glance

Nov 10, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 10, 2021

    4 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ENTECAVIR

Strength

0.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 208195

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ENTECAVIR

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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