Details for New Drug Application (NDA): 021443

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NDA 021443 describes ENJUVIA, which is a drug marketed by Aspen and is included in one NDA. Additional details are available on the ENJUVIA profile page.

The generic ingredient in ENJUVIA is estrogens, conjugated synthetic b. There are three drug master file entries for this compound. Additional details are available on the estrogens, conjugated synthetic b profile page.

Summary for 021443

Tradename:	ENJUVIA
Applicant:	Aspen
Ingredient:	estrogens, conjugated synthetic b
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.3MG
Approval Date:	Dec 20, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.45MG
Approval Date:	Dec 20, 2004	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 10, 2004	TE:		RLD:	No

Expired US Patents for NDA 021443

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-005	Apr 27, 2007	⤷ Sign Up	⤷ Sign Up
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-001	Dec 20, 2004	⤷ Sign Up	⤷ Sign Up
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-002	Dec 20, 2004	⤷ Sign Up	⤷ Sign Up
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-004	May 10, 2004	⤷ Sign Up	⤷ Sign Up
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-003	May 10, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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