← FDA DRUG APPROVALS

FDA NDA · NDA009175

NITROFURANTOIN

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA009175
TYPE
NDA
ORIGINAL APPROVAL
1953-12-23
LATEST ACTION
2024-02-01
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

FURADANTIN · ReferencePrescription
NITROFURANTOIN 50MG/5ML · SUSPENSION · ORAL
FURADANTIN · ReferencePrescription
NITROFURANTOIN 25MG/5ML · SUSPENSION · ORAL

Approval history

2024-02-01Labeling · Supplement 50 · standard — Letter ↗AP
2023-06-09Manufacturing (CMC) · Supplement 49 — Letter ↗AP
2020-12-23Labeling · Supplement 48 · standard — Label ↗AP
2019-06-11Labeling · Supplement 46 · standard — Label ↗AP
2016-07-11Manufacturing (CMC) · Supplement 44 · standardAP
2014-11-03Manufacturing (CMC) · Supplement 43 · standardAP
2013-11-04Labeling · Supplement 36 · standard — Letter ↗AP
2010-10-27Labeling · Supplement 38 · standard — Letter ↗AP
2010-10-14Labeling · Supplement 39 · unknown — Letter ↗AP
2009-02-06Labeling · Supplement 37 · standard — Letter ↗AP
2008-05-30Labeling · Supplement 33 · standard — Letter ↗AP
1999-08-25Labeling · Supplement 26 · standardAP
1999-02-11Labeling · Supplement 20 · standardAP
1998-12-03Manufacturing (CMC) · Supplement 25 · standardAP
1998-04-07Labeling · Supplement 22 · standardAP
1997-03-27Labeling · Supplement 23 · standardAP
1996-10-15Manufacturing (CMC) · Supplement 24 · standardAP
1993-08-09Manufacturing (CMC) · Supplement 21 · standardAP
1993-05-18Efficacy · Supplement 15AP
1988-05-13Labeling · Supplement 19 — Review ↗AP
1987-06-12Labeling · Supplement 16AP
1987-06-12Labeling · Supplement 12AP
1982-11-18Labeling · Supplement 13AP
1980-04-25Labeling · Supplement 10AP
1979-12-17Labeling · Supplement 11AP
1978-01-03Manufacturing (CMC) · Supplement 8 · standardAP
1973-11-23Supplement · Supplement 6 · standardAP
1953-12-23Type 3 - New Dosage Form · 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 →