Application 207417
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
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 |
|---|---|---|---|---|---|
| 43602-177 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Ascent Pharmaceuticals, Inc. | ANDA | Current |
| 43602-178 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Ascent Pharmaceuticals, Inc. | ANDA | Current |