FdaApplication
NDA 202788
Identifiers
- fda_app_no: NDA202788
Properties
| Property | Value |
|---|---|
| applicant_name | BTCP PHARMA LLC |
| application_type | NDA |
| approval_date | 2012-01-04 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SUBSYS | FENTANYL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL |
| SUBSYS | FENTANYL | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL |
| SUBSYS | FENTANYL | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL |
| SUBSYS | FENTANYL | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL |
| SUBSYS | FENTANYL | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL |
| SUBSYS | FENTANYL | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL |
| SUBSYS | FENTANYL | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY;SUBLINGUAL |
7 products