FdaApplication
NDA 216117
Identifiers
- fda_app_no: NDA216117
Properties
| Property | Value |
|---|---|
| applicant_name | OSMOTICA PHARMACEUTICAL US LLC |
| application_type | NDA |
| approval_date | 2022-06-23 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL |
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL |
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL |
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE;ORAL |
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL |
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 63MG | TABLET, EXTENDED RELEASE;ORAL |
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 45MG | TABLET, EXTENDED RELEASE;ORAL |
7 products