FdaApplication
ANDA 080643
Identifiers
- fda_app_no: ANDA080643
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 12.5MG/5ML | ELIXIR;ORAL |
1 product