← FDA DRUG APPROVALS

FDA ANDA · ANDA207372

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

nitrofurantoin monohydrate/macrocrystals

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA207372
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-15
LATEST ACTION
2024-05-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Discontinued
NITROFURANTOIN 75MG, NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL

Approval history

2024-05-09Labeling · Supplement 16 · standardAP
2017-05-15UNKNOWN · Original · standardAP
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.

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 →