Application 209450
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUBIPROSTONE | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No |
| 002 | LUBIPROSTONE | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-475 | Lubiprostone | Lubiprostone | AvKARE | ANDA | Current |
| 42291-476 | Lubiprostone | Lubiprostone | AvKARE | ANDA | Current |
| 65162-841 | Lubiprostone | Lubiprostone | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-841 | Lubiprostone | Lubiprostone | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-842 | Lubiprostone | Lubiprostone | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-842 | Lubiprostone | Lubiprostone | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67809 | ORIG | 2021-06-15 |