Application 214387
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DROXIDOPA | DROXIDOPA | CAPSULE;ORAL | 100MG | No | No |
| 002 | DROXIDOPA | DROXIDOPA | CAPSULE;ORAL | 200MG | No | No |
| 003 | DROXIDOPA | DROXIDOPA | CAPSULE;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-375 | Droxidopa | Droxidopa | Aurobindo Pharma Limited | ANDA | Current |
| 59651-375 | Droxidopa | Droxidopa | Aurobindo Pharma Limited | ANDA | Current |
| 59651-376 | Droxidopa | Droxidopa | Aurobindo Pharma Limited | ANDA | Current |
| 59651-376 | Droxidopa | Droxidopa | Aurobindo Pharma Limited | ANDA | Current |
| 59651-377 | Droxidopa | Droxidopa | Aurobindo Pharma Limited | ANDA | Current |
| 59651-377 | Droxidopa | Droxidopa | Aurobindo Pharma Limited | ANDA | Current |