Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206406

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ENVARSUS XR (TACROLIMUS)
EQ 0.75MG BASE
Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: ENVARSUS XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 0.75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206406
Product Number: 001
Approval Date: Jul 10, 2015
Applicant Holder Full Name: VELOXIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENVARSUS XR (TACROLIMUS)
EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: ENVARSUS XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206406
Product Number: 002
Approval Date: Jul 10, 2015
Applicant Holder Full Name: VELOXIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENVARSUS XR (TACROLIMUS)
EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: TACROLIMUS
Proprietary Name: ENVARSUS XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206406
Product Number: 003
Approval Date: Jul 10, 2015
Applicant Holder Full Name: VELOXIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information