FDA NDA · NDA204200

ADRENALIN

epinephrine

Sponsor: PH HEALTH

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APPLICATION
NDA204200
TYPE
NDA
ORIGINAL APPROVAL
2012-12-07
LATEST ACTION
2026-10-19
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ADRENALIN · ReferencePrescription
EPINEPHRINE EQ 1MG BASE/ML (EQ 1MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Approval history

2026-10-19Labeling · Supplement 23 · standard — Label ↗AP
2023-01-05Labeling · Supplement 18 · standard — Letter ↗AP
2019-01-29Efficacy · Supplement 9 · standard — Label ↗AP
2017-08-09Labeling · Supplement 7 · standard — Label ↗AP
2016-09-12Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2016-05-18Labeling · Supplement 5 · 901 required — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 3 · standardAP
2014-07-31Manufacturing (CMC) · Supplement 1 · standardAP
2012-12-07Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
2012-12-07Efficacy · Original · priorityAP
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