Details for New Drug Application (NDA): 204447
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The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen 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 204447
Tradename: | TRINTELLIX |
Applicant: | Takeda Pharms Usa |
Ingredient: | vortioxetine hydrobromide |
Patents: | 10 |
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 | Cardinal Health 107, LLC | 55154-0256 | 55154-0256-8 | 2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8) |
TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447 | NDA | Cardinal Health 107, LLC | 55154-0257 | 55154-0257-8 | 2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Sep 30, 2013 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jan 22, 2024 | ||||||||
Regulatory Exclusivity Use: | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | ||||||||
Regulatory Exclusivity Expiration: | Aug 23, 2026 | ||||||||
Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
Regulatory Exclusivity Expiration: | Feb 23, 2027 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY |
Expired US Patents for NDA 204447
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-001 | Sep 30, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | Sep 30, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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