Details for New Drug Application (NDA): 203202

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 six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the droxidopa profile page.

Summary for 203202

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

Pharmacology for NDA: 203202

Physiological Effect

Increased Blood Pressure

Medical Subject Heading (MeSH) Categories for 203202

Antiparkinson Agents

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Feb 18, 2014	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Feb 18, 2014	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Feb 18, 2014	TE:	AB	RLD:	Yes

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