FdaApplication
ANDA 078453
Identifiers
- fda_app_no: ANDA078453
Properties
| Property | Value |
|---|---|
| applicant_name | ORBION PHARMACEUTICALS PRIVATE LTD |
| application_type | ANDA |
| approval_date | 2009-07-02 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET;ORAL |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET;ORAL |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET;ORAL |
3 products