FdaApplication
ANDA 075315
Identifiers
- fda_app_no: ANDA075315
Properties
| Property | Value |
|---|---|
| applicant_name | UPSHER SMITH LABORATORIES LLC |
| application_type | ANDA |
| approval_date | 1998-12-23 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | TABLET;ORAL |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 400MG | TABLET;ORAL |
2 products