Orange Book product · Generic (ANDA)

EXENATIDE SYNTHETIC

Generic (ANDA)ANDA 206697RX AMNEAL

View EXENATIDE SYNTHETIC family Open on FDA Orange Book

At a glance

Nov 19, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 19, 2024
1 yr 7 mo ago
Today

Pharmaceutical detail

Active ingredient

EXENATIDE SYNTHETIC

Strength

300MCG/1.2ML (250MCG/ML)

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

TE code

Not listed

Application

ANDA 206697

Product number

001

Marketing status

Reference listed drug (RLD)

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of EXENATIDE SYNTHETIC

BYDUREON BCISEBrand (NDA)
NDA 209210 · ASTRAZENECA AB
2017
BYDUREONBrand (NDA)
NDA 022200 · ASTRAZENECA AB
2012
BYETTABrand (NDA)
NDA 021773 · ASTRAZENECA AB
2005

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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