Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203202
Company: LUNDBECK NA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORTHERA DROXIDOPA 100MG CAPSULE;ORAL Prescription None Yes No
NORTHERA DROXIDOPA 200MG CAPSULE;ORAL Prescription None Yes No
NORTHERA DROXIDOPA 300MG CAPSULE;ORAL Prescription None Yes Yes
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.cfm
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.

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

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