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Generated: April 22, 2018

DrugPatentWatch Database Preview

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-nine 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
Therapeutic Class:	Antidepressants
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	N	0052-0105-30
REMERON	mirtazapine	TABLET;ORAL	020415	NDA	Organon USA Inc.	0052-0107	N	0052-0107-30

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:	RX	Dosage:	TABLET;ORAL			Strength	45MG
Approval Date:	Mar 17, 1997	TE:	AB	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 Usa Inc	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997	➤ Sign Up	➤ Sign Up
Organon Usa Inc	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996	➤ Sign Up	➤ Sign Up
Organon Usa Inc	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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