APPLICATION
ANDA205180
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-03
LATEST ACTION
2024-11-12
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
NITROFURANTOINPrescription
NITROFURANTOIN 25MG/5ML · SUSPENSION · ORAL
Approval history
2024-11-12Labeling · Supplement 5 · standardAP
2024-11-12Labeling · Supplement 4 · standardAP
2016-05-03UNKNOWN · 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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