← FDA DRUG APPROVALS
FDA ANDA · ANDA074967
NITROFURANTOIN (MACROCRYSTALS)
Sponsor: AUROBINDO PHARMA USA
APPLICATION
ANDA074967
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-09
LATEST ACTION
2023-12-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 50MG · CAPSULE · ORAL
Approval history
2023-12-11Labeling · Supplement 15 · standardAP
2015-01-15Labeling · Supplement 12 · standardAP
2012-11-14Labeling · Supplement 11 · standardAP
2012-09-18Labeling · Supplement 10 · standardAP
2011-11-02Manufacturing (CMC) · Supplement 9AP
2003-09-25Labeling · Supplement 4AP
2003-04-28Labeling · Supplement 3AP
1998-08-03Labeling · Supplement 2AP
1998-01-27Manufacturing (CMC) · Supplement 1AP
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.