FdaApplication
NDA 019697
Identifiers
- fda_app_no: NDA019697
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1992-07-03 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ORTHO TRI-CYCLEN | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 |
| ORTHO TRI-CYCLEN | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 |
2 products