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FDA NDA · NDA021773

BYETTA

exenatide

Sponsor: ASTRAZENECA AB

APPLICATION
NDA021773
TYPE
NDA
ORIGINAL APPROVAL
2005-04-28
LATEST ACTION
2025-09-02
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BYETTA · ReferenceDiscontinued
EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) · INJECTABLE · SUBCUTANEOUS
BYETTA · ReferenceDiscontinued
EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2025-09-02Labeling · Supplement 51 · standardLabelAP
2025-05-28Labeling · Supplement 50 · standardLetterAP
2024-11-01Labeling · Supplement 49 · 901 requiredLabelAP
2022-12-21Labeling · Supplement 48 · standardLetterAP
2022-06-10Labeling · Supplement 46 · standardLetterAP
2022-06-10Labeling · Supplement 47 · 901 requiredLetterAP
2021-11-04Efficacy · Supplement 45 · standardLabelAP
2021-06-17Labeling · Supplement 44 · standardLetterAP
2020-02-28Labeling · Supplement 43 · standardLabelAP
2018-12-20Labeling · Supplement 41 · standardLabelAP
2015-02-25Labeling · Supplement 40 · 901 requiredLabelAP
2014-11-24Efficacy · Supplement 36 · standardLetterAP
2014-08-12Manufacturing (CMC) · Supplement 39 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 38 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 37 · standardAP
2014-04-23Manufacturing (CMC) · Supplement 35 · standardAP
2014-01-30Manufacturing (CMC) · Supplement 34 · standardAP
2011-10-19Efficacy · Supplement 30 · standardLabelAP
2011-10-19Efficacy · Supplement 29 · standardLetterAP
2011-08-05REMS · Supplement 31LetterAP
2010-11-12Labeling · Supplement 28 · unknownLabelAP
2010-08-13Labeling · Supplement 26 · unknownLetterAP
2009-10-30Labeling · Supplement 18 · standardLabelAP
2009-10-30Labeling · Supplement 22 · standardLetterAP
2009-10-30REMS · Supplement 25 · unknownLabelAP
2009-10-30Labeling · Supplement 17 · standardLabelAP
2009-10-30Labeling · Supplement 9 · standardLetterAP
2009-10-30Labeling · Supplement 11 · standardLetterAP
2008-06-17Labeling · Supplement 10 · standardLabelAP
2008-01-11Labeling · Supplement 12 · standardLetterAP
2007-02-10Manufacturing (CMC) · Supplement 7LabelAP
2006-12-22Labeling · Supplement 6 · standardLabelAP
2006-12-22Efficacy · Supplement 2 · unknownLetterAP
2006-11-01Labeling · Supplement 5 · standardLabelAP
2006-10-12Labeling · Supplement 4 · standardLabelAP
2005-04-28Type 1 - New Molecular Entity · Original · standardLabelAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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