FdaApplication
ANDA 205629
Identifiers
- fda_app_no: ANDA205629
Properties
| Property | Value |
|---|---|
| applicant_name | OSMOTICA PHARMACEUTICAL US LLC |
| application_type | ANDA |
| approval_date | 2016-07-07 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE;ORAL |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE;ORAL |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE;ORAL |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE;ORAL |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE;ORAL |
5 products