Last Updated: September 24, 2026

Details for New Drug Application (NDA): 210929

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NDA 210929 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-three suppliers. Additional details are available on the TACROLIMUS profile page.

The generic ingredient in TACROLIMUS is tacrolimus. There is one drug master file entry for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

Summary for 210929

Tradename:	TACROLIMUS
Applicant:	Hangzhou Zhongmei
Ingredient:	tacrolimus
Patents:	0

Medical Subject Heading (MeSH) Categories for 210929

Calcineurin Inhibitors
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Apr 17, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 1MG BASE
Approval Date:	Apr 17, 2023	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Apr 17, 2023	TE:		RLD:	No

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