FdaApplication
ANDA 076655
Identifiers
- fda_app_no: ANDA076655
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2018-03-21 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL |
4 products