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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207372

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE)
75MG;25MG
Marketing Status: Prescription
Active Ingredient: NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Proprietary Name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207372
Product Number: 001
Approval Date: May 15, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status:  Prescription
Patent and Exclusivity Information
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