Product Details for ANDA 203740
TACROLIMUS (TACROLIMUS)
EQ 0.5MG BASE
Marketing Status: Prescription
EQ 1MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
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: A203740
Product Number: 001
Approval Date: Nov 12, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
TACROLIMUS (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: A203740
Product Number: 001
Approval Date: Nov 12, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A203740
Product Number: 002
Approval Date: Nov 12, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
TACROLIMUS (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: A203740
Product Number: 002
Approval Date: Nov 12, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A203740
Product Number: 003
Approval Date: Nov 12, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A203740
Product Number: 003
Approval Date: Nov 12, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information