FdaApplication
NDA 019977
Identifiers
- fda_app_no: NDA019977
Properties
| Property | Value |
|---|---|
| applicant_name | XANODYNE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1991-08-15 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ORAMORPH SR | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL |
| ORAMORPH SR | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL |
| ORAMORPH SR | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL |
| ORAMORPH SR | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL |
4 products