APPLICATION
ANDA077066
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-05
LATEST ACTION
2023-08-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Prescription
NITROFURANTOIN 75MG, NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
Approval history
2023-08-08Labeling · Supplement 29 · standardAP
2023-08-08Labeling · Supplement 21 · standardAP
2014-03-24Labeling · Supplement 16 · standardAP
2011-10-12Labeling · Supplement 8AP
2005-04-05OriginalAP
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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