FdaApplication
NDA 019856
Identifiers
- fda_app_no: NDA019856
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC |
| application_type | NDA |
| approval_date | 1991-05-30 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SINEMET CR | CARBIDOPA; LEVODOPA | 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| SINEMET CR | CARBIDOPA; LEVODOPA | 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
2 products