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Last Updated: October 24, 2021

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Details for New Drug Application (NDA): 090687


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NDA 090687 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 090687
Tradename:TACROLIMUS
Applicant:Strides Pharma
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090687
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 090687
Suppliers and Packaging for NDA: 090687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 090687 ANDA Major Pharmaceuticals 0904-7097 0904-7097-61 100 BLISTER PACK in 1 CARTON (0904-7097-61) > 1 CAPSULE in 1 BLISTER PACK
TACROLIMUS tacrolimus CAPSULE;ORAL 090687 ANDA Strides Pharma Science Limited 64380-720 64380-720-01 10 BLISTER PACK in 1 CARTON (64380-720-01) > 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Jul 22, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Jul 22, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Jul 22, 2014TE:ABRLD:No

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