FdaApplication
NDA 018024
Identifiers
- fda_app_no: NDA018024
Properties
| Property | Value |
|---|---|
| applicant_name | PH HEALTH LTD |
| application_type | NDA |
| approval_date | 1982-05-27 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NUBAIN | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| NUBAIN | NALBUPHINE HYDROCHLORIDE | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| NUBAIN | NALBUPHINE HYDROCHLORIDE | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| NUBAIN | NALBUPHINE HYDROCHLORIDE | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| NUBAIN | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
5 products