Details for New Drug Application (NDA): 022436

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NDA 022436 describes XERESE, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the XERESE profile page.

The generic ingredient in XERESE is acyclovir; hydrocortisone. There are fifty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acyclovir; hydrocortisone profile page.

Summary for 022436

Tradename:	XERESE
Applicant:	Bausch
Ingredient:	acyclovir; hydrocortisone
Patents:	0

Pharmacology for NDA: 022436

Mechanism of Action	Corticosteroid Hormone Receptor Agonists DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 022436

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436	NDA	Bausch Health US LLC	0187-5104	0187-5104-01	1 TUBE in 1 CARTON (0187-5104-01) / 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%;1%
Approval Date:	Jul 31, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022436

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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