Application 210818
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47781-415 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-415 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-415 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-416 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-416 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-416 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-417 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-417 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-417 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-418 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-418 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |
| 47781-418 | Methylphenidate hydrochloride | Methylphenidate hydrochloride | Alvogen Inc. | ANDA | Current |