Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090687

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

Active Ingredient: TACROLIMUS
Proprietary Name: TACROLIMUS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090687
Product Number: 001
Approval Date: Jul 22, 2014
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: TACROLIMUS
Proprietary Name: TACROLIMUS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090687
Product Number: 002
Approval Date: Jul 22, 2014
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: TACROLIMUS
Proprietary Name: TACROLIMUS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090687
Product Number: 003
Approval Date: Jul 22, 2014
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information