← FDA DRUG APPROVALS

FDA NDA · NDA016620

NITROFURANTOIN MACROCRYSTALS

Sponsor: ALMATICA

APPLICATION
NDA016620
TYPE
NDA
ORIGINAL APPROVAL
1970-06-05
LATEST ACTION
2021-01-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MACRODANTIN · ReferencePrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
MACRODANTIN · ReferencePrescription
NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
MACRODANTIN · ReferencePrescription
NITROFURANTOIN, MACROCRYSTALLINE 50MG · CAPSULE · ORAL

Approval history

2021-01-21Labeling · Supplement 76 · standard — Letter ↗AP
2015-10-15Manufacturing (CMC) · Supplement 74 · standardAP
2015-10-02Manufacturing (CMC) · Supplement 73 · standardAP
2013-09-06Labeling · Supplement 72 · standard — Label ↗AP
2011-06-06Labeling · Supplement 70 · standard — Letter ↗AP
2009-03-05Labeling · Supplement 68 · standard — Letter ↗AP
2007-09-14Labeling · Supplement 67 · standard — Letter ↗AP
2004-03-29Labeling · Supplement 65 · standard — Letter ↗AP
2003-02-04Labeling · Supplement 64 · standard — Review ↗AP
1998-10-21Manufacturing (CMC) · Supplement 63 · standard — Review ↗AP
1998-02-17Labeling · Supplement 58 · standardAP
1998-02-17Labeling · Supplement 56 · standardAP
1997-07-16Labeling · Supplement 62 · standard — Review ↗AP
1997-03-27Labeling · Supplement 61 · standardAP
1996-07-30Manufacturing (CMC) · Supplement 60 · standardAP
1996-03-07Manufacturing (CMC) · Supplement 59 · standard — Review ↗AP
1993-08-09Manufacturing (CMC) · Supplement 57 · standard — Review ↗AP
1993-05-19Labeling · Supplement 39AP
1993-05-18Labeling · Supplement 36AP
1992-12-08Manufacturing (CMC) · Supplement 54 · standard — Review ↗AP
1992-12-08Manufacturing (CMC) · Supplement 52 · standardAP
1992-12-08Manufacturing (CMC) · Supplement 55 · standard — Review ↗AP
1992-12-08Manufacturing (CMC) · Supplement 53 · standard — Review ↗AP
1991-04-10Manufacturing (CMC) · Supplement 51 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 49 · standardAP
1990-07-09Manufacturing (CMC) · Supplement 50 · standardAP
1989-01-03Manufacturing (CMC) · Supplement 47 · standard — Review ↗AP
1988-05-13Labeling · Supplement 45 — Review ↗AP
1984-07-09Manufacturing (CMC) · Supplement 38 · standardAP
1983-06-02Manufacturing (CMC) · Supplement 37 · standardAP
1982-10-15Labeling · Supplement 31AP
1982-05-13Manufacturing (CMC) · Supplement 35 · standardAP
1980-12-12Labeling · Supplement 32AP
1980-08-14Manufacturing (CMC) · Supplement 30 · standardAP
1980-05-20Manufacturing (CMC) · Supplement 28 · standardAP
1979-12-18Labeling · Supplement 26AP
1979-07-26Manufacturing (CMC) · Supplement 25 · standardAP
1979-07-16Manufacturing (CMC) · Supplement 27 · standardAP
1978-07-28Labeling · Supplement 23AP
1977-05-13Manufacturing (CMC) · Supplement 21 · standardAP
VIEW ON DRUGS@FDA ↗

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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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