Application 211818
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
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 |
|---|
| 70710-1389 | Droxidopa | Droxidopa | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1390 | Droxidopa | Droxidopa | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1391 | Droxidopa | Droxidopa | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1609 | Droxidopa | Droxidopa | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1609 | Droxidopa | Droxidopa | Cadila Healthcare Limited | ANDA | Current |
| 70771-1610 | Droxidopa | Droxidopa | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1610 | Droxidopa | Droxidopa | Cadila Healthcare Limited | ANDA | Current |
| 70771-1611 | Droxidopa | Droxidopa | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1611 | Droxidopa | Droxidopa | Cadila Healthcare Limited | ANDA | Current |