Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050708

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PROGRAF (TACROLIMUS)
EQ 0.5MG BASE
Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: PROGRAF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050708
Product Number: 003
Approval Date: Aug 24, 1998
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PROGRAF (TACROLIMUS)
EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: PROGRAF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050708
Product Number: 001
Approval Date: Apr 8, 1994
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PROGRAF (TACROLIMUS)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: PROGRAF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050708
Product Number: 002
Approval Date: Apr 8, 1994
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information