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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 020415


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NDA 020415 describes REMERON, which is a drug marketed by Organon and Organon Usa Organon 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-five suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 020415
Tradename:REMERON
Applicant:Organon
Ingredient:mirtazapine
Patents:0
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 REMEDYREPACK INC. 70518-3955 70518-3955-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3955-0)
REMERON mirtazapine TABLET;ORAL 020415 NDA Organon LLC 78206-160 78206-160-01 1 BOTTLE in 1 CARTON (78206-160-01) / 30 TABLET, FILM COATED in 1 BOTTLE

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 REMERON mirtazapine TABLET;ORAL 020415-001 Jun 14, 1996 5,977,099 ⤷  Subscribe
Organon REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997 5,977,099 ⤷  Subscribe
Organon REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 5,977,099 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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