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Serving leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Medtronic
Accenture
Farmers Insurance
Fish and Richardson
Chinese Patent Office
Dow
McKinsey
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Generated: November 19, 2017

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. Forty-eight suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Summary for 020415

Tradename:
1
Applicant:
1
Ingredient:
1
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 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

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Mar 17, 1997TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020415

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-001Jun 14, 1996► Subscribe► Subscribe
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-003Mar 17, 1997► Subscribe► Subscribe
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-002Jun 14, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cipla
Dow
Teva
Harvard Business School
US Army
Colorcon
Accenture
AstraZeneca
Argus Health
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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