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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 090402

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NDA 090402 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 090402

Tradename:	TACROLIMUS
Applicant:	Heritage Pharma Avet
Ingredient:	tacrolimus
Patents:	0

Medical Subject Heading (MeSH) Categories for 090402

Calcineurin Inhibitors
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 1, 2010	TE:		RLD:	No

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