← FDA DRUG APPROVALS

FDA NDA · NDA213407

EMERPHED

ephedrine sulfate

Sponsor: NEXUS

APPLICATION
NDA213407
TYPE
NDA
ORIGINAL APPROVAL
2020-04-17
LATEST ACTION
2024-08-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EMERPHED · ReferencePrescription
EPHEDRINE SULFATE 50MG/10ML (5MG/ML) · SOLUTION · INTRAVENOUS
EMERPHED · ReferencePrescription
EPHEDRINE SULFATE 25MG/5ML (5MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-08-15Labeling · Supplement 9 · standard — Label ↗AP
2023-02-28Manufacturing (CMC) · Supplement 4 — Label ↗AP
2020-04-17Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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