APPLICATION
ANDA073652
TYPE
ANDA
ORIGINAL APPROVAL
1993-01-28
LATEST ACTION
2015-04-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
Approval history
2015-04-17Labeling · Supplement 21AP
2015-04-17Labeling · Supplement 29 · standardAP
2011-10-12Labeling · Supplement 28AP
2009-04-15Labeling · Supplement 26AP
2008-01-16Labeling · Supplement 24AP
2008-01-16Labeling · Supplement 23AP
2002-07-29Manufacturing (CMC) · Supplement 10AP
2001-09-12Manufacturing (CMC) · Supplement 8AP
2000-08-02Manufacturing (CMC) · Supplement 6AP
2000-08-02Labeling · Supplement 7AP
1999-11-29Labeling · Supplement 5AP
1999-09-14Labeling · Supplement 4AP
1998-02-13Labeling · Supplement 3AP
1997-05-12Labeling · Supplement 2AP
1993-05-21Manufacturing (CMC) · Supplement 1AP
1993-01-28OriginalAP
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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