← FDA DRUG APPROVALS

FDA ANDA · ANDA217521

PHENYLEPHRINE HYDROCHLORIDE

Sponsor: BE PHARMS

APPLICATION
ANDA217521
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-26
LATEST ACTION
2023-06-26
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-06-26UNKNOWN · Original · standardAP
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 →