FdaApplication
NDA 007961
Identifiers
- fda_app_no: NDA007961
Properties
| Property | Value |
|---|---|
| applicant_name | APTALIS PHARMA US INC |
| application_type | NDA |
| approval_date | 1984-10-15 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
1 product