FdaApplication
ANDA 091116
Identifiers
- fda_app_no: ANDA091116
Properties
| Property | Value |
|---|---|
| applicant_name | JUBILANT GENERICS LTD |
| application_type | ANDA |
| approval_date | 2015-02-19 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL |
4 products