FdaApplication
ANDA 204602
Identifiers
- fda_app_no: ANDA204602
Properties
| Property | Value |
|---|---|
| applicant_name | NOVEL LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2015-08-14 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL |
2 products