FdaApplication
NDA 022321
Identifiers
- fda_app_no: NDA022321
Properties
| Property | Value |
|---|---|
| applicant_name | ALPHARMA PHARMACEUTICALS LLC |
| application_type | NDA |
| approval_date | 2009-08-13 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
| EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL |
6 products