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Serving leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
AstraZeneca
Julphar
Queensland Health
McKinsey
Boehringer Ingelheim
US Department of Justice
Mallinckrodt
Argus Health

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203202

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NDA 203202 describes NORTHERA, which is a drug marketed by Lundbeck Na Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the NORTHERA profile page.

The generic ingredient in NORTHERA is droxidopa. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the droxidopa profile page.

Summary for 203202

Tradename:1
Applicant:1
Ingredient:1
Patents:0

Pharmacology for NDA: 203202

Ingredient-typeCatecholamines
Physiological EffectIncreased Blood Pressure

Medical Subject Heading (MeSH) Categories for 203202

Suppliers and Packaging for NDA: 203202

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTHERA droxidopa CAPSULE;ORAL 203202 NDA Lundbeck Pharmaceuticals LLC 67386-820 67386-820-19 90 CAPSULE in 1 BOTTLE (67386-820-19)
NORTHERA droxidopa CAPSULE;ORAL 203202 NDA Lundbeck Pharmaceuticals LLC 67386-821 67386-821-19 90 CAPSULE in 1 BOTTLE (67386-821-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 18, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 18, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 18, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Feb 18, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 18, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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Serving leading biopharmaceutical companies globally:

Covington
Julphar
Mallinckrodt
Daiichi Sankyo
Cerilliant
Novartis
Queensland Health
US Army
Colorcon
US Department of Justice

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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