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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217108

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NDA 217108 describes TACROLIMUS, which is a drug marketed by Chengdu, Accord Hlthcare, Ajenat Pharms, Alkem Labs Ltd, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Nexus, Encube, and Fougera Pharms Inc, and is included in twenty NDAs. It is available from thirty-one 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-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

Summary for 217108

Tradename:	TACROLIMUS
Applicant:	Nexus
Ingredient:	tacrolimus
Patents:	0

Pharmacology for NDA: 217108

Mechanism of Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for 217108

Calcineurin Inhibitors
Immunosuppressive Agents

Suppliers and Packaging for NDA: 217108

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TACROLIMUS	tacrolimus	INJECTABLE;INJECTION	217108	ANDA	Nexus Pharmaceuticals, LLC	14789-135	14789-135-05	10 VIAL in 1 CARTON (14789-135-05) / 1 mL in 1 VIAL (14789-135-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Feb 12, 2025	TE:	AP	RLD:	No

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