Application 074376
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 25MG | No | No |
| 002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1785 | Diclofenac Sodium | Diclofenac Sodium | Sandoz Inc | ANDA | Current |
| 0781-1787 | Diclofenac Sodium | Diclofenac Sodium | Sandoz Inc | ANDA | Current |
| 55289-166 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 68001-201 | Diclofenac Sodium | Diclofenac Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-202 | Diclofenac Sodium | Diclofenac Sodium | BluePoint Laboratories | ANDA | Current |
| 68151-2481 | Diclofenac Sodium | Diclofenac Sodium | Carilion Materials Management | ANDA | Current |