← FDA DRUG APPROVALS

FDA NDA · NDA215875

ADRENALIN (EPINEPHRINE IN SODIUM CHLORIDE)

epinephrine in sodium chloride

Sponsor: PH HEALTH

APPLICATION
NDA215875
TYPE
NDA
ORIGINAL APPROVAL
2023-04-21
LATEST ACTION
2023-10-19
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ADRENALIN · ReferencePrescription
EPINEPHRINE 10MG/250ML (40MCG/ML) · SOLUTION · INTRAVENOUS
ADRENALIN · ReferencePrescription
EPINEPHRINE 5MG/250ML (20MCG/ML) · SOLUTION · INTRAVENOUS
ADRENALIN · ReferencePrescription
EPINEPHRINE 2MG/250ML (8MCG/ML) · SOLUTION · INTRAVENOUS
ADRENALIN · ReferencePrescription
EPINEPHRINE 8MG/250ML (32MCG/ML) · SOLUTION · INTRAVENOUS
ADRENALIN · ReferencePrescription
EPINEPHRINE 4MG/250ML (16MCG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-10-19Labeling · Supplement 1 · standard — Label ↗AP
2023-04-21Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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