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Last Updated: September 25, 2023

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 one supplier. 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-four 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
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 LLC	78206-160	78206-160-01	1 BOTTLE in 1 CARTON (78206-160-01) / 30 TABLET, FILM COATED in 1 BOTTLE
REMERON	mirtazapine	TABLET;ORAL	020415	NDA	Organon LLC	78206-161	78206-161-01	1 BOTTLE in 1 CARTON (78206-161-01) / 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jun 14, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Jun 14, 1996	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 17, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020415

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

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