FdaApplication
NDA 022442
Identifiers
- fda_app_no: NDA022442
Properties
| Property | Value |
|---|---|
| applicant_name | PERSION PHARMACEUTICALS LLC |
| application_type | NDA |
| approval_date | 2011-06-08 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| REZIRA | HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL |
1 product