Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016620

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MACRODANTIN (NITROFURANTOIN, MACROCRYSTALLINE)
25MG
Marketing Status: Prescription

Active Ingredient: NITROFURANTOIN, MACROCRYSTALLINE
Proprietary Name: MACRODANTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N016620
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MACRODANTIN (NITROFURANTOIN, MACROCRYSTALLINE)
50MG
Marketing Status: Prescription

Active Ingredient: NITROFURANTOIN, MACROCRYSTALLINE
Proprietary Name: MACRODANTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N016620
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MACRODANTIN (NITROFURANTOIN, MACROCRYSTALLINE)
100MG
Marketing Status: Prescription

Active Ingredient: NITROFURANTOIN, MACROCRYSTALLINE
Proprietary Name: MACRODANTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N016620
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information