Assyro AI

Orange Book product · Brand (NDA)

BYETTA

EXENATIDE SYNTHETIC

Brand (NDA)NDA 021773DISCN ASTRAZENECA AB
View EXENATIDE SYNTHETIC familyOpen on FDA Orange Book

At a glance

Apr 28, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 28, 2005

    21 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

EXENATIDE SYNTHETIC

Strength

600MCG/2.4ML (250MCG/ML)

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 021773

Product number

002

Marketing status

DISCN

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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