← FDA DRUG APPROVALS

FDA ANDA · ANDA209784

EPHEDRINE SULFATE

Sponsor: SANDOZ

APPLICATION
ANDA209784
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-23
LATEST ACTION
2020-11-24
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EPHEDRINE SULFATEPrescription
EPHEDRINE SULFATE 50MG/ML (50MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-11-24Labeling · Supplement 2 · standardAP
2019-10-28Labeling · Supplement 1 · standardAP
2017-08-23UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →