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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 206651


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NDA 206651 describes TACROLIMUS, which is a drug marketed by Chengdu, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Encube, and Fougera Pharms Inc, and is included in nineteen NDAs. It is available from thirty-two 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-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 206651
Tradename:TACROLIMUS
Applicant:Belcher
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206651
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 206651
Suppliers and Packaging for NDA: 206651
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 206651 ANDA BPI LABS LLC 54288-135 54288-135-01 100 CAPSULE in 1 BOTTLE (54288-135-01)
TACROLIMUS tacrolimus CAPSULE;ORAL 206651 ANDA Belcher Pharmaceuticals,LLC 62250-665 62250-665-02 100 CAPSULE in 1 BOTTLE (62250-665-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Nov 30, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Nov 30, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Nov 30, 2017TE:ABRLD:No

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