FdaApplication
NDA 204592
Identifiers
- fda_app_no: NDA204592
Properties
| Property | Value |
|---|---|
| applicant_name | ZYLA LIFE SCIENCES US INC |
| application_type | NDA |
| approval_date | 2013-10-18 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZORVOLEX | DICLOFENAC | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| ZORVOLEX | DICLOFENAC | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
2 products