Application 065429
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFDINIR | CEFDINIR | FOR SUSPENSION;ORAL | 125MG/5ML | No | No |
| 002 | CEFDINIR | CEFDINIR | FOR SUSPENSION;ORAL | 250MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42043-251 | Cefdinir | Cefdinir | OrchidPharma Inc | ANDA | Current |
| 42043-252 | Cefdinir | Cefdinir | OrchidPharma Inc | ANDA | Current |
| 68071-3393 | Cefdinir | Cefdinir | NuCare Pharmaceauticals,Inc. | ANDA | Current |
| 68071-4236 | Cefdinir | Cefdinir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6840 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6840 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |