Application 065337
- Type
- ANDA
- Sponsor
- SANDOZ
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 | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-6077 | Cefdinir | Cefdinir | Sandoz Inc | ANDA | Current |
| 0781-6077 | Cefdinir | Cefdinir | Sandoz Inc | ANDA | Current |
| 0781-6077 | Cefdinir | Cefdinir | Sandoz Inc | ANDA | Current |
| 0781-6078 | Cefdinir | Cefdinir | Sandoz Inc | ANDA | Current |
| 0781-6078 | Cefdinir | Cefdinir | Sandoz Inc | ANDA | Current |
| 0781-6078 | Cefdinir | Cefdinir | Sandoz Inc | ANDA | Current |
| 68788-7255 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7255 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-183 | Cefdinir | Cefdinir | Proficient Rx LP | ANDA | Current |
| 71205-183 | Cefdinir | Cefdinir | Proficient Rx LP | ANDA | Current |