FdaApplication
ANDA 206793
Identifiers
- fda_app_no: ANDA206793
Properties
| Property | Value |
|---|---|
| applicant_name | NOVEL LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2016-03-08 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL |
2 products