Details for New Drug Application (NDA): 019080

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NDA 019080 describes PROSOM, which is a drug marketed by Abbott and is included in one NDA. Additional details are available on the PROSOM profile page.

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

Summary for 019080

Tradename:	PROSOM
Applicant:	Abbott
Ingredient:	estazolam
Patents:	0

Medical Subject Heading (MeSH) Categories for 019080

Anti-Anxiety Agents
Anticonvulsants
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 26, 1990	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 26, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019080

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-002	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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