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Last Updated: November 2, 2024

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-eight 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 2, 2010TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 27, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING DEPRESSION
Patent:⤷  Sign UpPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 2, 2010TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 27, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING DEPRESSION

Expired US Patents for NDA 022411

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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