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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212387

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NDA 212387 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 212387

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

Pharmacology for NDA: 212387

Mechanism of Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for 212387

Calcineurin Inhibitors
Immunosuppressive Agents

Suppliers and Packaging for NDA: 212387

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TACROLIMUS	tacrolimus	OINTMENT;TOPICAL	212387	ANDA	Encube Ethicals, Inc.	21922-011	21922-011-05	1 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE
TACROLIMUS	tacrolimus	OINTMENT;TOPICAL	212387	ANDA	Encube Ethicals, Inc.	21922-011	21922-011-07	1 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.1%
Approval Date:	Oct 10, 2023	TE:	BX	RLD:	No

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