FdaApplication
ANDA 078558
Identifiers
- fda_app_no: ANDA078558
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL PHARMACEUTICALS NY LLC |
| application_type | ANDA |
| approval_date | 2007-06-18 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL |
| IBUPROFEN | IBUPROFEN | 400MG | TABLET;ORAL |
| IBUPROFEN | IBUPROFEN | 800MG | TABLET;ORAL |
3 products