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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203202
Company: LUNDBECK NA LTD

Products on NDA 203202

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORTHERA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	AB	Yes	No
NORTHERA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	AB	Yes	No
NORTHERA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203202

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203202Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203202Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203202s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203202Orig1s007ltr.pdf
10/03/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203202s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203202Orig1s006ltr.pdf
08/24/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/19/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/03/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/30/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/03/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203202

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203202s007lbl.pdf
10/03/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203202s006lbl.pdf
02/18/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203202lbl.pdf

Therapeutic Equivalents for NDA 203202

NORTHERA

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	215265	ADAPTIS
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	213911	ALKEM LABS LTD
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	211726	ANNORA
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214387	AUROBINDO PHARMA LTD
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	213033	BIONPHARMA
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214391	JUBILANT CADISTA
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	211741	MSN PHARMS INC
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214017	SCIEGEN PHARMS
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214543	SOMERSET THERAPS LLC
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	214384	SUN PHARM
DROXIDOPA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	No	AB	211818	ZYDUS PHARMS
NORTHERA	DROXIDOPA	100MG	CAPSULE;ORAL	Prescription	Yes	AB	203202	LUNDBECK NA LTD

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	215265	ADAPTIS
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	213911	ALKEM LABS LTD
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	211726	ANNORA
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214387	AUROBINDO PHARMA LTD
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	213033	BIONPHARMA
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214391	JUBILANT CADISTA
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	211741	MSN PHARMS INC
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214017	SCIEGEN PHARMS
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214543	SOMERSET THERAPS LLC
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	214384	SUN PHARM
DROXIDOPA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	No	AB	211818	ZYDUS PHARMS
NORTHERA	DROXIDOPA	200MG	CAPSULE;ORAL	Prescription	Yes	AB	203202	LUNDBECK NA LTD

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	215265	ADAPTIS
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	213911	ALKEM LABS LTD
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	211726	ANNORA
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214387	AUROBINDO PHARMA LTD
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	213033	BIONPHARMA
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214391	JUBILANT CADISTA
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	211741	MSN PHARMS INC
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214017	SCIEGEN PHARMS
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214543	SOMERSET THERAPS LLC
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	214384	SUN PHARM
DROXIDOPA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	No	AB	211818	ZYDUS PHARMS
NORTHERA	DROXIDOPA	300MG	CAPSULE;ORAL	Prescription	Yes	AB	203202	LUNDBECK NA LTD

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