← FDA DRUG APPROVALS

FDA NDA · NDA020064

NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE

nitrofurantoin monohydrate/macrocrystalline

Sponsor: ALMATICA

APPLICATION
NDA020064
TYPE
NDA
ORIGINAL APPROVAL
1991-12-24
LATEST ACTION
2023-03-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MACROBID · ReferencePrescription
NITROFURANTOIN 75MG, NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL

Approval history

2023-03-02Manufacturing (CMC) · Supplement 33 — Letter ↗AP
2021-01-21Labeling · Supplement 29 · standard — Letter ↗AP
2014-01-07Manufacturing (CMC) · Supplement 22 · standardAP
2013-09-06Labeling · Supplement 21 · standard — Letter ↗AP
2011-06-06Labeling · Supplement 20 · standard — Letter ↗AP
2009-03-05Labeling · Supplement 19 · standard — Letter ↗AP
2007-06-27Labeling · Supplement 17 · standard — Letter ↗AP
2003-10-30Labeling · Supplement 14 · standard — Letter ↗AP
2003-02-04Labeling · Supplement 13 · standard — Letter ↗AP
1999-11-03Manufacturing (CMC) · Supplement 11 · standardAP
1999-09-15Manufacturing (CMC) · Supplement 10 · standardAP
1998-02-17Labeling · Supplement 9 · standardAP
1998-02-17Labeling · Supplement 5 · standardAP
1997-07-16Labeling · Supplement 8 · standardAP
1997-03-27Labeling · Supplement 7 · standardAP
1996-02-20Labeling · Supplement 2 · standardAP
1995-02-13Manufacturing (CMC) · Supplement 6 · standardAP
1993-08-23Manufacturing (CMC) · Supplement 4 · standardAP
1993-08-09Manufacturing (CMC) · Supplement 3 · standardAP
1992-07-24Manufacturing (CMC) · Supplement 1 · standardAP
1991-12-24Type 3 - New Dosage Form · Original · standardAP
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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.

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