FdaApplication
NDA 018354
Identifiers
- fda_app_no: NDA018354
Properties
| Property | Value |
|---|---|
| applicant_name | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1982-01-11 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ORTHO-NOVUM 10/11-21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 |
| ORTHO-NOVUM 10/11-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG;0.5MG,1MG | TABLET;ORAL-28 |
2 products