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FDA ANDA · ANDA209225
NITROFURANTOIN
nitrofurantoin (monohydrate/macrocrystals)
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA209225
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-30
LATEST ACTION
2023-03-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Prescription
NITROFURANTOIN 75MG, NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
Approval history
2023-03-30UNKNOWN · 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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