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FDA NDA · NDA213994

EPHEDRINE SULFATE

Sponsor: PH HEALTH

APPLICATION
NDA213994
TYPE
NDA
ORIGINAL APPROVAL
2020-10-16
LATEST ACTION
2022-04-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2022-04-22Manufacturing (CMC) · Supplement 4 — Label ↗AP
2020-10-16Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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