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Application 214896
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRIMIDONE | PRIMIDONE | TABLET;ORAL | 50MG | No | No |
| 002 | PRIMIDONE | PRIMIDONE | TABLET;ORAL | 250MG | No | No |
| 003 | PRIMIDONE | PRIMIDONE | TABLET;ORAL | 125MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72888-045 | Primidone | Primidone | Advagen Pharma Limited | ANDA | Current |
| 72888-045 | Primidone | Primidone | Advagen Pharma Limited | ANDA | Current |
| 72888-046 | Primidone | Primidone | Advagen Pharma Limited | ANDA | Current |
| 72888-046 | Primidone | Primidone | Advagen Pharma Limited | ANDA | Current |
| 72888-160 | Primidone | Primidone | Advagen Pharma Limited | ANDA | Current |