APPLICATION
ANDA074336
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-25
LATEST ACTION
2022-04-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
NITROFURANTOINDiscontinued
NITROFURANTOIN, MACROCRYSTALLINE 50MG · CAPSULE · ORAL
NITROFURANTOINDiscontinued
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
NITROFURANTOINDiscontinued
NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
Approval history
2022-04-08Labeling · Supplement 10 · standardAP
2022-04-08Labeling · Supplement 11 · standardAP
2002-04-19Manufacturing (CMC) · Supplement 8AP
2002-03-12Manufacturing (CMC) · Supplement 6AP
2001-11-06Manufacturing (CMC) · Supplement 7AP
2001-08-16Manufacturing (CMC) · Supplement 5AP
2000-11-30Manufacturing (CMC) · Supplement 4AP
2000-03-21Labeling · Supplement 2AP
1999-12-13Labeling · Supplement 1AP
1995-01-25OriginalAP
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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