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 is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the droxidopa profile page.
The generic ingredient in NORTHERA is droxidopa. There is one drug master file entry for this compound. Fourteen 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
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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