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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 009175

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FURADANTIN (NITROFURANTOIN)
25MG/5ML
Marketing Status: Prescription
Active Ingredient: NITROFURANTOIN
Proprietary Name: FURADANTIN
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 25MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N009175
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CASPER PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FURADANTIN (NITROFURANTOIN)
50MG/5ML
Marketing Status: Prescription
Active Ingredient: NITROFURANTOIN
Proprietary Name: FURADANTIN
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 50MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N009175
Product Number: 002
Approval Date: Jun 9, 2023
Applicant Holder Full Name: CASPER PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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