Application 208607
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 18MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 27MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 36MG | No | No |
| 004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 54MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62559-790 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-790 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-791 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-791 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63371 | ORIG | 2020-06-01 |