Details for New Drug Application (NDA): 022411

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NDA 022411 describes OLEPTRO, which is a drug marketed by Angelini Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OLEPTRO profile page.

The generic ingredient in OLEPTRO 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 022411

Tradename:	OLEPTRO
Applicant:	Angelini Pharma
Ingredient:	trazodone hydrochloride
Patents:	2

Medical Subject Heading (MeSH) Categories for 022411

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 2, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 27, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING DEPRESSION
Patent:	⤷ Sign Up	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TABLET, EXTENDED RELEASE;ORAL			Strength	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 2, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 27, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING DEPRESSION

Expired US Patents for NDA 022411

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010	⤷ Sign Up	⤷ Sign Up
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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