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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 020415


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NDA 020415 describes REMERON, which is a drug marketed by Organon Usa Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the REMERON profile page.

The generic ingredient in REMERON is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 020415
Tradename:REMERON
Applicant:Organon Usa Inc
Ingredient:mirtazapine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020415
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REMERON mirtazapine TABLET;ORAL 020415 NDA Organon USA Inc. 0052-0105 0052-0105-30 1 BOTTLE in 1 CARTON (0052-0105-30) > 30 TABLET, FILM COATED in 1 BOTTLE
REMERON mirtazapine TABLET;ORAL 020415 NDA Organon USA Inc. 0052-0107 0052-0107-30 1 BOTTLE in 1 CARTON (0052-0107-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Paragraph IV (Patent) Challenges for 020415
Tradename Dosage Ingredient NDA Submissiondate
REMERON TABLET;ORAL mirtazapine 020415

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jun 14, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jun 14, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 17, 1997TE:RLD:Yes

Expired US Patents for NDA 020415

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-001 Jun 14, 1996   Start Trial   Start Trial
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997   Start Trial   Start Trial
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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