FdaApplication
ANDA 205327
Identifiers
- fda_app_no: ANDA205327
Properties
| Property | Value |
|---|---|
| applicant_name | OSMOTICA PHARMACEUTICAL US LLC |
| application_type | ANDA |
| approval_date | 2017-07-28 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL |
5 products