FdaApplication
ANDA 088587
Identifiers
- fda_app_no: ANDA088587
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 1984-07-02 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL |
1 product