Details for New Drug Application (NDA): 018207

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NDA 018207 describes DESYREL, which is a drug marketed by Pragma and is included in one NDA. There is one patent protecting this drug. Additional details are available on the DESYREL profile page.

The generic ingredient in DESYREL is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

Summary for 018207

Tradename:	DESYREL
Applicant:	Pragma
Ingredient:	trazodone hydrochloride
Patents:	1

Medical Subject Heading (MeSH) Categories for 018207

Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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
Patent:	8,133,893	Patent Expiration:	Mar 13, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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
Patent:	8,133,893	Patent Expiration:	Mar 13, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 25, 1985	TE:		RLD:	Yes
Patent:	8,133,893	Patent Expiration:	Mar 13, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 018207

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	4,215,104	⤷ Get Started Free
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	4,258,027	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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