Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065040

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CYCLOSPORINE (CYCLOSPORINE)
25MG
Marketing Status: Prescription

Active Ingredient: CYCLOSPORINE
Proprietary Name: CYCLOSPORINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A065040
Product Number: 001
Approval Date: May 9, 2002
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CYCLOSPORINE (CYCLOSPORINE)
100MG
Marketing Status: Prescription

Active Ingredient: CYCLOSPORINE
Proprietary Name: CYCLOSPORINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A065040
Product Number: 002
Approval Date: May 9, 2002
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information