FDA NDA · NDA204200

ADRENALIN

epinephrine

Sponsor: PH HEALTH

APPLICATION

NDA204200

TYPE

NDA

ORIGINAL APPROVAL

2012-12-07

LATEST ACTION

2023-01-05

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

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

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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