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Details for New Drug Application (NDA): 204447

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NDA 204447 describes TRINTELLIX, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the TRINTELLIX profile page.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.

Summary for NDA: 204447

Tradename:
TRINTELLIX
Applicant:
Takeda Pharms Usa
Ingredient:
vortioxetine hydrobromide
Patents:5
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204447

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL 204447 NDA Takeda Pharmaceuticals America, Inc. 64764-550 64764-550-07 1 BOTTLE in 1 CARTON (64764-550-07) > 7 TABLET, FILM COATED in 1 BOTTLE
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL 204447 NDA Takeda Pharmaceuticals America, Inc. 64764-550 64764-550-09 30 TABLET, FILM COATED in 1 BOTTLE (64764-550-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 30, 2013TE:RLD:No
Patent:8,722,684Patent Expiration:Jun 30, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:7,144,884Patent Expiration:Jan 9, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
Patent:8,476,279Patent Expiration:Oct 2, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION


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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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