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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021302

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NDA 021302 describes ELIDEL, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. Additional details are available on the ELIDEL profile page.

The generic ingredient in ELIDEL is pimecrolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.

Summary for 021302

Tradename:	ELIDEL
Applicant:	Bausch
Ingredient:	pimecrolimus
Patents:	0

Pharmacology for NDA: 021302

Mechanism of Action	Calcineurin Inhibitors

Suppliers and Packaging for NDA: 021302

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELIDEL	pimecrolimus	CREAM;TOPICAL	021302	NDA	Bausch Health US, LLC	0187-5100	0187-5100-01	1 TUBE in 1 CARTON (0187-5100-01) / 30 g in 1 TUBE
ELIDEL	pimecrolimus	CREAM;TOPICAL	021302	NDA	Bausch Health US, LLC	0187-5101	0187-5101-02	1 TUBE in 1 CARTON (0187-5101-02) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Dec 13, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021302

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	⤷ Get Started Free	⤷ Get Started Free
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	⤷ Get Started Free	⤷ Get Started Free
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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