Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214384
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | AB | No | No |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/18/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DROXIDOPA
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 |
| DROXIDOPA | DROXIDOPA | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214543 | BLUEPHARMA INDUSTRIA |
| 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 | 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 |
| DROXIDOPA | DROXIDOPA | 200MG | CAPSULE;ORAL | Prescription | No | AB | 214543 | BLUEPHARMA INDUSTRIA |
| 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 | 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 |
| DROXIDOPA | DROXIDOPA | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214543 | BLUEPHARMA INDUSTRIA |
| 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 | 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 |