FdaApplication
ANDA 212133
Identifiers
- fda_app_no: ANDA212133
Properties
| Property | Value |
|---|---|
| applicant_name | ASCENT PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2020-09-23 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE;ORAL |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE;ORAL |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE;ORAL |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE;ORAL |
4 products