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FDA NDA · NDA204640

ADRENALIN

epinephrine

Sponsor: PH HEALTH

APPLICATION
NDA204640
TYPE
NDA
ORIGINAL APPROVAL
2013-12-18
LATEST ACTION
2026-06-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ADRENALIN · ReferencePrescription
EPINEPHRINE EQ 30MG BASE/30ML (EQ 1MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Approval history

2026-06-22Labeling · Supplement 22 · standard — Letter ↗AP
2023-01-05Labeling · Supplement 18 · standard — Letter ↗AP
2021-08-17Manufacturing (CMC) · Supplement 12 — Review ↗AP
2019-01-29Efficacy · Supplement 9 · standard — Label ↗AP
2017-08-09Labeling · Supplement 8 · standard — Label ↗AP
2016-05-18Labeling · Supplement 3 · 901 required — Label ↗AP
2015-12-23Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2013-12-18Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗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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