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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 is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the droxidopa profile page.

Summary for NDA: 203202

Tradename:
NORTHERA
Applicant:
Lundbeck Na Ltd
Ingredient:
droxidopa
Patents:0

Pharmacology for NDA: 203202

Ingredient-typeCatecholamines
Physiological EffectIncreased Blood Pressure

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 LLC 67386-820 67386-820-19 90 CAPSULE in 1 BOTTLE (67386-820-19)
NORTHERA
droxidopa
CAPSULE;ORAL 203202 NDA Lundbeck 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:No
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:No
Regulatory Exclusivity Expiration:Feb 18, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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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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