FdaApplication
NDA 021217
Identifiers
- fda_app_no: NDA021217
Properties
| Property | Value |
|---|---|
| applicant_name | SPECGX LLC |
| application_type | NDA |
| approval_date | 2010-03-01 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| EXALGO | HYDROMORPHONE HYDROCHLORIDE | 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| EXALGO | HYDROMORPHONE HYDROCHLORIDE | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| EXALGO | HYDROMORPHONE HYDROCHLORIDE | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| EXALGO | HYDROMORPHONE HYDROCHLORIDE | 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
4 products