Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050715

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NEORAL (CYCLOSPORINE)
25MG
Marketing Status: Prescription

Active Ingredient: CYCLOSPORINE
Proprietary Name: NEORAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N050715
Product Number: 001
Approval Date: Jul 14, 1995
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

NEORAL (CYCLOSPORINE)
100MG
Marketing Status: Prescription

Active Ingredient: CYCLOSPORINE
Proprietary Name: NEORAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB1
Application Number: N050715
Product Number: 002
Approval Date: Jul 14, 1995
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

NEORAL (CYCLOSPORINE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CYCLOSPORINE
Proprietary Name: NEORAL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050715
Product Number: 003
Approval Date: Jul 14, 1995
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information