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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 212297

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NDA 212297 describes TACROLIMUS, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Heritage Pharma, Mylan, Panacea, Sandoz, Strides Pharma, Hospira Inc, and Fougera Pharms Inc, and is included in sixteen NDAs. It is available from twenty-six suppliers. Additional details are available on the TACROLIMUS profile page.

The generic ingredient in TACROLIMUS is tacrolimus. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 212297
Applicant:Biocon Pharma
Formulation / Manufacturing:see details
Pharmacology for NDA: 212297
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 212297
Suppliers and Packaging for NDA: 212297
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 212297 ANDA Cardinal Health 55154-4080 55154-4080-8 2000 CAPSULE in 1 BOTTLE (55154-4080-8)
TACROLIMUS tacrolimus CAPSULE;ORAL 212297 ANDA Biocon Pharma Inc. 70377-014 70377-014-11 100 CAPSULE in 1 BOTTLE (70377-014-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Nov 10, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Nov 10, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Nov 10, 2020TE:ABRLD:No

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