← FDA DRUG APPROVALS

FDA ANDA · ANDA216385

NITROFURANTOIN

Sponsor: NOVITIUM PHARMA

APPLICATION
ANDA216385
TYPE
ANDA
ORIGINAL APPROVAL
2023-04-14
LATEST ACTION
2023-04-14
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NITROFURANTOINPrescription
NITROFURANTOIN 25MG/5ML · SUSPENSION · ORAL

Approval history

2023-04-14UNKNOWN · 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 →