Details for New Drug Application (NDA): 020992

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NDA 020992 describes CENESTIN, which is a drug marketed by Aspen and is included in one NDA. Additional details are available on the CENESTIN profile page.

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

Summary for 020992

Tradename:	CENESTIN
Applicant:	Aspen
Ingredient:	estrogens, conjugated synthetic a
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 21, 2002	TE:		RLD:	Yes

Profile for product number 002

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DISCN	Dosage:	TABLET;ORAL			Strength	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	Mar 24, 1999	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.9MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 24, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020992

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-004	Mar 13, 2000	5,908,638	⤷ Subscribe
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-001	Jun 21, 2002	5,908,638	⤷ Subscribe
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-003	Mar 24, 1999	5,908,638	⤷ Subscribe
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-002	Mar 24, 1999	5,908,638	⤷ Subscribe
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-005	Feb 5, 2004	5,908,638	⤷ Subscribe
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