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Details for New Drug Application (NDA): 018207

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NDA 018207 describes DESYREL, which is a drug marketed by Pragma Pharms Llc 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 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: 018207

Tradename:
DESYREL
Applicant:
Pragma Pharms Llc
Ingredient:
trazodone hydrochloride
Patents:1
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No
Patent:8,133,893Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?YDelist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No
Patent:8,133,893Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?YDelist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Mar 25, 1985TE:RLD:No
Patent:8,133,893Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 018207

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-003Mar 25, 19854,215,104► subscribe
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-003Mar 25, 19854,258,027► subscribe
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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.

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