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Orange Book product · Generic (ANDA)

ESZOPICLONE

ESZOPICLONE

Generic (ANDA)ANDA 205504TE ABRX HETERO LABS LTD V
View ESZOPICLONE familyOpen on FDA Orange Book

At a glance

Jan 04, 2024

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 04, 2024

    2 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESZOPICLONE

Strength

1MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 205504

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ESZOPICLONE

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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