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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020064

MACROBID (NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE)
75MG;25MG
Marketing Status: Prescription
Active Ingredient: NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Proprietary Name: MACROBID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG;25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020064
Product Number: 001
Approval Date: Dec 24, 1991
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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