Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203202
Company: LUNDBECK NA LTD
Company: LUNDBECK NA LTD
| 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 |
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 |
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 | 214391 | AJANTA PHARMA LTD |
| 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 INC |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212835 | HIKMA |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211652 | LUPIN PHARMS |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211741 | MSN PHARMS INC |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214017 | SCIEGEN PHARMS INC |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 215265 | SLATE RUN PHARMA |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214384 | SUN PHARM |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214543 | TRIS PHARMA INC |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213661 | UPSHER SMITH LABS |
| 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 | 214391 | AJANTA PHARMA LTD |
| 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 INC |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 212835 | HIKMA |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 211652 | LUPIN PHARMS |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 211741 | MSN PHARMS INC |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 214017 | SCIEGEN PHARMS INC |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 215265 | SLATE RUN PHARMA |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 214384 | SUN PHARM |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 214543 | TRIS PHARMA INC |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 213661 | UPSHER SMITH LABS |
| 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 | 214391 | AJANTA PHARMA LTD |
| 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 INC |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 212835 | HIKMA |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211652 | LUPIN PHARMS |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211741 | MSN PHARMS INC |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214017 | SCIEGEN PHARMS INC |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 215265 | SLATE RUN PHARMA |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214384 | SUN PHARM |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214543 | TRIS PHARMA INC |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 213661 | UPSHER SMITH LABS |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211818 | ZYDUS PHARMS |
| NORTHERA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 203202 | LUNDBECK NA LTD |