Details for New Drug Application (NDA): 018116

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NDA 018116 describes CYCLOCORT, which is a drug marketed by Astellas and is included in three NDAs. Additional details are available on the CYCLOCORT profile page.

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

Summary for 018116

Tradename:	CYCLOCORT
Applicant:	Astellas
Ingredient:	amcinonide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018116

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-002	Approved Prior to Jan 1, 1982	4,158,055	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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