Details for New Drug Application (NDA): 021385

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NDA 021385 describes ERTACZO, which is a drug marketed by Lacer Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the ERTACZO profile page.

The generic ingredient in ERTACZO is sertaconazole nitrate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the sertaconazole nitrate profile page.

Summary for 021385

Tradename:	ERTACZO
Applicant:	Lacer Pharma
Ingredient:	sertaconazole nitrate
Patents:	0

Pharmacology for NDA: 021385

Suppliers and Packaging for NDA: 021385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Bausch Health US, LLC	0187-5115	0187-5115-60	1 TUBE in 1 CARTON (0187-5115-60) / 60 g in 1 TUBE
ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Lacer Pharma, LLC	73159-004	73159-004-60	1 TUBE in 1 CARTON (73159-004-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	2%
Approval Date:	Dec 10, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021385

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385-001	Dec 10, 2003	5,135,943	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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