FdaApplication
NDA 006134
Identifiers
- fda_app_no: NDA006134
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA PHARMS |
| application_type | NDA |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/30ML | SYRUP;ORAL |
| DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
3 products