Application 074358
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLURBIPROFEN | FLURBIPROFEN | TABLET;ORAL | 50MG | No | No |
| 002 | FLURBIPROFEN | FLURBIPROFEN | TABLET;ORAL | 100MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0076 | Flurbiprofen | flurbiprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0076 | Flurbiprofen | flurbiprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0093 | Flurbiprofen | flurbiprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0093 | Flurbiprofen | flurbiprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 55289-561 | Flurbiprofen | flurbiprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-561 | Flurbiprofen | flurbiprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |