FdaApplication
ANDA 205107
Identifiers
- fda_app_no: ANDA205107
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL PHARMACEUTICALS OF NEW YORK LLC |
| application_type | ANDA |
| approval_date | 2020-09-04 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL |
2 products