Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203202

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NORTHERA (DROXIDOPA)
100MG
Marketing Status: Prescription

Active Ingredient: DROXIDOPA
Proprietary Name: NORTHERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203202
Product Number: 001
Approval Date: Feb 18, 2014
Applicant Holder Full Name: LUNDBECK NA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

NORTHERA (DROXIDOPA)
200MG
Marketing Status: Prescription

Active Ingredient: DROXIDOPA
Proprietary Name: NORTHERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203202
Product Number: 002
Approval Date: Feb 18, 2014
Applicant Holder Full Name: LUNDBECK NA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

NORTHERA (DROXIDOPA)
300MG
Marketing Status: Prescription

Active Ingredient: DROXIDOPA
Proprietary Name: NORTHERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N203202
Product Number: 003
Approval Date: Feb 18, 2014
Applicant Holder Full Name: LUNDBECK NA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information