Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204096

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ASTAGRAF XL (TACROLIMUS)
EQ 0.5MG BASE Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: ASTAGRAF XL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204096
Product Number: 001
Approval Date: Jul 19, 2013
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ASTAGRAF XL (TACROLIMUS)
EQ 1MG BASE Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: ASTAGRAF XL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204096
Product Number: 002
Approval Date: Jul 19, 2013
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ASTAGRAF XL (TACROLIMUS)
EQ 5MG BASE Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: ASTAGRAF XL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204096
Product Number: 003
Approval Date: Jul 19, 2013
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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