FdaApplication
NDA 005213
Identifiers
- fda_app_no: NDA005213
Properties
| Property | Value |
|---|---|
| applicant_name | GENUS LIFESCIENCES INC |
| application_type | NDA |
| approval_date | 1988-07-26 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
2 products