FdaApplication
NDA 021879
Identifiers
- fda_app_no: NDA021879
Properties
| Property | Value |
|---|---|
| applicant_name | OTSUKA AMERICA PHARMACEUTICAL INC |
| application_type | NDA |
| approval_date | 2010-10-29 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NUEDEXTA | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | 20MG;10MG | CAPSULE;ORAL |
1 product