APPLICATION
ANDA205005
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-12
LATEST ACTION
2022-02-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 50MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
Approval history
2022-02-08Labeling · Supplement 3 · standardAP
2022-02-08Labeling · Supplement 1 · standardAP
2017-12-12UNKNOWN · Original · standardAP
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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