← FDA DRUG APPROVALS

FDA NDA · NDA019430

EPIPEN

epinephrine

Sponsor: VIATRIS

APPLICATION
NDA019430
TYPE
NDA
ORIGINAL APPROVAL
1987-12-22
LATEST ACTION
2026-03-20
ROUTE
INTRAMUSCULAR, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

EPIPEN E Z PENDiscontinued
EPINEPHRINE 0.3MG/DELIVERY · INJECTABLE · INTRAMUSCULAR
EPIPEN · ReferencePrescription
EPINEPHRINE 0.3MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
EPI E Z PEN JRDiscontinued
EPINEPHRINE 0.15MG/DELIVERY · INJECTABLE · INTRAMUSCULAR
EPIPEN JR. · ReferencePrescription
EPINEPHRINE 0.15MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2026-03-20Manufacturing (CMC) · Supplement 120 — Letter ↗AP
2023-02-10Labeling · Supplement 106 · standard — Letter ↗AP
2020-12-24Labeling · Supplement 91 · standard — Label ↗AP
2020-06-17Labeling · Supplement 89 · standard — Letter ↗AP
2020-01-31Labeling · Supplement 82 · standard — Label ↗AP
2018-08-23Labeling · Supplement 74 · standard — Label ↗AP
2017-04-28Labeling · Supplement 67 · standard — Letter ↗AP
2016-05-18Labeling · Supplement 61 · 901 required — Review ↗AP
2016-03-03Manufacturing (CMC) · Supplement 60 · standardAP
2014-07-17Labeling · Supplement 58 · standard — Letter ↗AP
2014-04-30Labeling · Supplement 59 · standard — Review ↗AP
2013-12-13Manufacturing (CMC) · Supplement 57 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 56 · standard — Review ↗AP
2013-09-16Manufacturing (CMC) · Supplement 55 · standard — Review ↗AP
2013-07-23Manufacturing (CMC) · Supplement 54 · standard — Review ↗AP
2012-08-20Labeling · Supplement 53 · standard — Label ↗AP
2009-05-19Labeling · Supplement 47 · standard — Letter ↗AP
2008-09-26Labeling · Supplement 44 · standard — Label ↗AP
2003-12-17Labeling · Supplement 25 · standard — Letter ↗AP
2002-12-19Manufacturing (CMC) · Supplement 18 · standardAP
2002-08-21Manufacturing (CMC) · Supplement 17 · standardAP
2002-06-28Manufacturing (CMC) · Supplement 16 · standardAP
2002-04-16Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
2002-02-20Manufacturing (CMC) · Supplement 14 · standardAP
2001-08-27Labeling · Supplement 12 · standard — Label ↗AP
2001-01-11Manufacturing (CMC) · Supplement 11 · standardAP
2000-05-11Manufacturing (CMC) · Supplement 10 · standardAP
1999-12-15Manufacturing (CMC) · Supplement 8 · standardAP
1999-11-05Manufacturing (CMC) · Supplement 9 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 7 · standardAP
1997-01-24Manufacturing (CMC) · Supplement 6 · standardAP
1996-07-25Manufacturing (CMC) · Supplement 5 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 4 · standardAP
1989-03-02Labeling · Supplement 1 — Review ↗AP
1987-12-22Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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