APPLICATION
ANDA208516
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-24
LATEST ACTION
2018-05-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Prescription
NITROFURANTOIN 75MG, NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
Approval history
2018-05-24UNKNOWN · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.