FdaApplication
NDA 018662
Identifiers
- fda_app_no: NDA018662
Properties
| Property | Value |
|---|---|
| applicant_name | HOFFMANN LA ROCHE INC |
| application_type | NDA |
| approval_date | 1982-05-07 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ACCUTANE | ISOTRETINOIN | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| ACCUTANE | ISOTRETINOIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| ACCUTANE | ISOTRETINOIN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
3 products