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FDA NDA · NDA020800

EPINEPHRINE

Sponsor: IMPAX

APPLICATION
NDA020800
TYPE
NDA
ORIGINAL APPROVAL
2003-05-30
LATEST ACTION
2026-03-19
ROUTE
SUBCUTANEOUS, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

ADRENACLICK · ReferencePrescription
EPINEPHRINE EQ 0.15MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
TWINJECTDiscontinued
EPINEPHRINE EQ 0.3MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
ADRENACLICK · ReferencePrescription
EPINEPHRINE EQ 0.3MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
TWINJECTDiscontinued
EPINEPHRINE EQ 0.15MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2026-03-19Labeling · Supplement 54 · standard — Letter ↗AP
2024-11-20Labeling · Supplement 52 · standard — Label ↗AP
2021-02-04Labeling · Supplement 40 · standard — Letter ↗AP
2018-08-29Labeling · Supplement 35 · standard — Label ↗AP
2016-05-18Labeling · Supplement 34 · 901 required — Review ↗AP
2014-10-23Manufacturing (CMC) · Supplement 28 · standardAP
2014-10-17Manufacturing (CMC) · Supplement 30 · standard — Letter ↗AP
2014-10-13Manufacturing (CMC) · Supplement 29 · standardAP
2014-07-25Labeling · Supplement 27 · standard — Letter ↗AP
2014-04-23Labeling · Supplement 24 · standard — Label ↗AP
2014-03-25Manufacturing (CMC) · Supplement 26 · standardAP
2014-03-24Manufacturing (CMC) · Supplement 25 · standardAP
2013-09-06Manufacturing (CMC) · Supplement 23 · standard — Review ↗AP
2011-01-26Labeling · Supplement 20 · standard — Label ↗AP
2009-11-25Manufacturing (CMC) · Supplement 18 — Label ↗AP
2006-12-28Manufacturing (CMC) · Supplement 11 · standard — Letter ↗AP
2005-07-07Labeling · Supplement 6 · standard — Letter ↗AP
2005-07-01Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2005-02-22Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2004-05-28Efficacy · Supplement 1 · unknown — Letter ↗AP
2003-05-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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