Application 209468
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1899 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1900 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1901 | Dexmethylphenidate Hydrochloride | dexmethylphenidate hydrochloride | Lannett Company, Inc. | ANDA | Current |