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Application 212390
- Type
- ANDA
- Sponsor
- DIPHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NITISINONE | NITISINONE | CAPSULE;ORAL | 2MG | No | No |
| 002 | NITISINONE | NITISINONE | CAPSULE;ORAL | 5MG | No | No |
| 003 | NITISINONE | NITISINONE | CAPSULE;ORAL | 10MG | No | No |
| 004 | NITISINONE | NITISINONE | CAPSULE;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70505-202 | Nitisinone | Nitisinone | Analog Pharma | ANDA | Current |
| 70505-202 | Nitisinone | Nitisinone | Analog Pharma | ANDA | Current |
| 70505-205 | Nitisinone | Nitisinone | Analog Pharma | ANDA | Current |
| 70505-205 | Nitisinone | Nitisinone | Analog Pharma | ANDA | Current |
| 70505-210 | Nitisinone | Nitisinone | Analog Pharma | ANDA | Current |
| 70505-210 | Nitisinone | Nitisinone | Analog Pharma | ANDA | Current |