Details for New Drug Application (NDA): 204141

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NDA 204141 describes TOPICORT, which is a drug marketed by Taro and is included in ten NDAs. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOPICORT profile page.

The generic ingredient in TOPICORT is desoximetasone. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.

Summary for 204141

Tradename:	TOPICORT
Applicant:	Taro
Ingredient:	desoximetasone
Patents:	2

Pharmacology for NDA: 204141

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 204141

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 204141

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPICORT	desoximetasone	SPRAY;TOPICAL	204141	NDA AUTHORIZED GENERIC	Taro Pharmaceuticals U.S.A., Inc.	51672-1396	51672-1396-3	1 BOTTLE, SPRAY in 1 CARTON (51672-1396-3) / 30 mL in 1 BOTTLE, SPRAY
TOPICORT	desoximetasone	SPRAY;TOPICAL	204141	NDA AUTHORIZED GENERIC	Taro Pharmaceuticals U.S.A., Inc.	51672-1396	51672-1396-4	1 BOTTLE, SPRAY in 1 CARTON (51672-1396-4) / 50 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;TOPICAL			Strength	0.25%
Approval Date:	Apr 11, 2013	TE:	AT	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 1, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
Patent:	⤷ Sign Up	Patent Expiration:	May 26, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER

Expired US Patents for NDA 204141

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taro	TOPICORT	desoximetasone	SPRAY;TOPICAL	204141-001	Apr 11, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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