Droxidopa Oral Capsule

Brand(s)
Northera
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lundbeck Inc. (2014-08-01)
Oldest Current Product
2014-09-01
License(s)
NDA
RxNORM
ORAL CAPSULE\DROXIDOPA
FDAOB
ORAL\CAPSULE\DROXIDOPA
SPL Active
ORAL\CAPSULE\DROXIDOPA
SPL Moiety
ORAL\CAPSULE\DROXIDOPA

product(s) by strength(s)

droxidopa 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860820NortheraNDALundbeck Inc.2014-09-01DROXIDOPAORALCAPSULENDA2032022179f02c-48d7-48eb-8007-5ae43d8d16bc

droxidopa 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860821NortheraNDALundbeck Inc.2014-09-01DROXIDOPAORALCAPSULENDA2032022179f02c-48d7-48eb-8007-5ae43d8d16bc

droxidopa 300 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860822NortheraNDALundbeck Inc.2014-09-01DROXIDOPAORALCAPSULENDA2032022179f02c-48d7-48eb-8007-5ae43d8d16bc

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA203202NORTHERALUNDBECK NA LTD2014-02-18ORPHAN DRUG EXCLUSIVITY [2021-02-18]
NEW CHEMICAL ENTITY [2019-02-18]
NDA203202_001, NDA203202_002, NDA203202_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203202_001RXDROXIDOPA (100MG)ORALCAPSULEFalse2014-02-18NORTHERA
2NDA203202_002RXDROXIDOPA (200MG)ORALCAPSULEFalse2014-02-18NORTHERA
3NDA203202_003RXDROXIDOPA (300MG)ORALCAPSULETrue2014-02-18NORTHERA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12179f02c-48d7-48eb-8007-5ae43d8d16bc (view SPL)These highlights do not include all the information needed to use NORTHERA safely and effectively. See full prescribing information for NORTHERA. NORTHERA (droxidopa) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionLundbeck Inc.MANUFACTURE2014-08-018673860820, 673860821, 673860822

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII