FdaApplication
ANDA 086057
Identifiers
- fda_app_no: ANDA086057
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | 0.025MG;2.5MG | TABLET;ORAL |
1 product