FdaApplication
ANDA 074391
Identifiers
- fda_app_no: ANDA074391
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 1995-06-29 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL |
3 products