Application 211652
- Type
- ANDA
- Sponsor
- LUPIN PHARMS
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68180-987 | DROXIDOPA | DROXIDOPA | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-987 | DROXIDOPA | DROXIDOPA | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-988 | DROXIDOPA | DROXIDOPA | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-988 | DROXIDOPA | DROXIDOPA | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-989 | DROXIDOPA | DROXIDOPA | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-989 | DROXIDOPA | DROXIDOPA | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66716 | ORIG | 2021-03-10 |