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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090802


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NDA 090802 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 090802
Tradename:TACROLIMUS
Applicant:Panacea
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090802
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 090802
Suppliers and Packaging for NDA: 090802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TACROLIMUS tacrolimus CAPSULE;ORAL 090802 ANDA Panacea Biotec Limited 43817-421 43817-421-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-421-01)
TACROLIMUS tacrolimus CAPSULE;ORAL 090802 ANDA Panacea Biotec Limited 43817-422 43817-422-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-422-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Sep 28, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Sep 28, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Sep 28, 2012TE:ABRLD:No

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