Application 091178
- Type
- ANDA
- Sponsor
- GENBIOPRO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIFEPRISTONE | MIFEPRISTONE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43393-001 | Mifepristone | MIFEPRISTONE | GenBioPro, Inc. | ANDA | Current |
| 43393-001 | Mifepristone | MIFEPRISTONE | GenBioPro, Inc. | ANDA | Current |
| 43393-001 | Mifepristone | MIFEPRISTONE | GenBioPro, Inc. | ANDA | Current |
| 43393-001 | Mifepristone | MIFEPRISTONE | GenBioPro Inc | ANDA | Current |
| 43393-001 | Mifepristone | MIFEPRISTONE | GenBioPro, Inc. | ANDA | Current |
| 83114-001 | MIFEPRISTONE | mifepristone | PCI Pharma Services Canada, Inc. | ANDA | Current |