FdaApplication
NDA 016059
Identifiers
- fda_app_no: NDA016059
Properties
| Property | Value |
|---|---|
| applicant_name | ZYLA LIFE SCIENCES US LLC |
| application_type | NDA |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| INDOCIN | INDOMETHACIN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| INDOCIN | INDOMETHACIN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
2 products