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FDA ANDA · ANDA077025
NITROFURANTOIN (MACROCRYSTALS)
Sponsor: AUROBINDO PHARMA USA
APPLICATION
ANDA077025
TYPE
ANDA
ORIGINAL APPROVAL
2004-08-18
LATEST ACTION
2024-10-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
Approval history
2024-10-02Manufacturing (CMC) · Supplement 9 · unknownAP
2023-12-11Labeling · Supplement 8 · standardAP
2015-01-15Labeling · Supplement 5 · standardAP
2012-11-14Labeling · Supplement 4 · standardAP
2012-09-18Labeling · Supplement 3 · standardAP
2011-11-02Manufacturing (CMC) · Supplement 2AP
2004-08-18OriginalAP
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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