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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 three 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 thirteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

Summary for NDA: 022411

Angelini Pharma
trazodone hydrochloride
Therapeutic Class:Antidepressants

Summary 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EXTENDED RELEASE;ORALStrength150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 2010TE:RLD:No
Patent:6,607,748Patent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,133,893Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:7,829,120Patent Expiration:Mar 27, 2027Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.