FdaApplication
NDA 013483
Identifiers
- fda_app_no: NDA013483
Properties
| Property | Value |
|---|---|
| applicant_name | SCHERING PLOUGH HEALTHCARE PRODUCTS INC |
| application_type | NDA |
| approval_date | 1982-09-13 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DISOPHROL | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 6MG;120MG | TABLET, EXTENDED RELEASE;ORAL |
| DRIXORAL | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
2 products