Application 210139
- Type
- ANDA
- Sponsor
- NOVELGENIX THERAPS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | SOLUTION;ORAL | 10MG/5ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63629-1175 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1175 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1176 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1176 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1176 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71930-024 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Eywa Pharma Inc | ANDA | Current |
| 71930-024 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Eywa Pharma Inc | ANDA | Current |
| 71930-024 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Eywa Pharma Inc | ANDA | Current |
| 71930-025 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Eywa Pharma Inc | ANDA | Current |
| 71930-025 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Eywa Pharma Inc | ANDA | Current |
| 71930-025 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Eywa Pharma Inc | ANDA | Current |